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OCUL

Ocular TherapeutixB
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-22
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Earnings documents stored for OCUL.

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Investor releaseQuarter not tagged2026-08-22

Ocular Therapeutix (OCUL) Could Be 59% Undervalued Following Earnings Beat And AXPAXLI Progress

Simply Wall St.
Find winning stocks in any market cycle. Join 7 million investors using Simply Wall St's investing ideas for FREE. Ocular Therapeutix (OCUL) is back in focus after its Q2 report, where revenues and earnings per share surpassed analyst expectations, and management outlined progress on AXPAXLI phase 3 trials with an FDA aligned path toward an NDA in Q4 2026. See our latest analysis for Ocular Therapeutix. Ocular Therapeutix shares have been volatile, with the 30 day share price return of 29.06% and 90 day share price return of 34.63% coming after Q2 results and recent investor events, while the 1 year total shareholder return is still down 9.92% even though the 3 year total shareholder return is very large at about 2x. If you are rethinking your exposure to healthcare and biotech after Ocular Therapeutix's recent move, it may be worth scanning a curated set of 41 healthcare AI stocks. The recent surge in Ocular Therapeutix raises a simple question. Are investors now re-rating the stock on the back of Q2 execution and AXPAXLI progress, or is sentiment running ahead of what the current valuation supports? Ocular Therapeutix last closed at $11.08, while the most widely followed fair value narrative points to $27.09, which is a much higher level and sets up a very optimistic roadmap for Axpaxli and the broader pipeline. The anticipated approval of AXPAXLI, potentially the first wet AMD product with a superiority label and longer dosing intervals (every 6 to 12 months), may allow Ocular Therapeutix to capture significant market share in a rapidly growing population of elderly patients with retinal disease unlocking large revenue growth opportunities as the global prevalence of ophthalmic disorders increases. Read the complete narrative. Want to see what kind of revenue build, margin shift, and future earnings multiple sit behind that fair value jump? The narrative lays out a detailed path, including how Axpaxli adoption and pipeline expansion feed into those projections. The full context matters far more than the headline number. Result: Fair Value of $27.09 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, the bullish Ocular Therapeutix story still hinges heavily on Axpaxli trial outcomes and regulatory decisions, while higher spending and dilution remain real swing factors. Find out about the key risks to this…Read full document

Find winning stocks in any market cycle. Join 7 million investors using Simply Wall St's investing ideas for FREE. Ocular Therapeutix (OCUL) is back in focus after its Q2 report, where revenues and earnings per share surpassed analyst expectations, and management outlined progress on AXPAXLI phase 3 trials with an FDA aligned path toward an NDA in Q4 2026. See our latest analysis for Ocular Therapeutix. Ocular Therapeutix shares have been volatile, with the 30 day share price return of 29.06% and 90 day share price return of 34.63% coming after Q2 results and recent investor events, while the 1 year total shareholder return is still down 9.92% even though the 3 year total shareholder return is very large at about 2x. If you are rethinking your exposure to healthcare and biotech after Ocular Therapeutix's recent move, it may be worth scanning a curated set of 41 healthcare AI stocks. The recent surge in Ocular Therapeutix raises a simple question. Are investors now re-rating the stock on the back of Q2 execution and AXPAXLI progress, or is sentiment running ahead of what the current valuation supports? Ocular Therapeutix last closed at $11.08, while the most widely followed fair value narrative points to $27.09, which is a much higher level and sets up a very optimistic roadmap for Axpaxli and the broader pipeline. The anticipated approval of AXPAXLI, potentially the first wet AMD product with a superiority label and longer dosing intervals (every 6 to 12 months), may allow Ocular Therapeutix to capture significant market share in a rapidly growing population of elderly patients with retinal disease unlocking large revenue growth opportunities as the global prevalence of ophthalmic disorders increases. Read the complete narrative. Want to see what kind of revenue build, margin shift, and future earnings multiple sit behind that fair value jump? The narrative lays out a detailed path, including how Axpaxli adoption and pipeline expansion feed into those projections. The full context matters far more than the headline number. Result: Fair Value of $27.09 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, the bullish Ocular Therapeutix story still hinges heavily on Axpaxli trial outcomes and regulatory decisions, while higher spending and dilution remain real swing factors. Find out about the key risks to this Ocular Therapeutix narrative. The analyst narrative and fair value of $27.09 rely heavily on long term revenue and margin assumptions for Ocular Therapeutix. The market today is telling a very different story, with a P/S ratio of 46.7x versus a peer average of 5.9x and a fair ratio of just 0.1x. That gap points to meaningful valuation risk if expectations reset. To see what the numbers say about this price, and how they compare with the fair ratio and peers, have a look at the detailed valuation breakdown in the See what the numbers say about this price — find out in our valuation breakdown.. Given the mix of optimism and caution in the Ocular Therapeutix story, it makes sense to move quickly and weigh the data directly. Use the detailed breakdown of 2 key rewards and 3 important warning signs. You have seen how quickly the story can change for Ocular Therapeutix. Do not stop there. Broaden your watchlist with fresh ideas that align with your risk and income goals. Explore potential opportunities in smaller companies that still meet quality filters by scanning the 22 elite penny stocks with strong financials. Concentrate on value-focused opportunities that combine quality and attractive pricing with the 48 high quality undervalued stocks. Identify companies with strong balance sheets and fundamentals using the solid balance sheet and fundamentals stocks screener (50 results). This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include OCUL. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Investor releaseQuarter not tagged2026-08-03

Ocular Therapeutix: Q2 Earnings Snapshot

Associated Press

BEDFORD, Mass. (AP) — BEDFORD, Mass. (AP) — Ocular Therapeutix Inc. (OCUL) on Monday reported a loss of $78.8 million in its second quarter. The Bedford, Massachusetts-based company said it had a loss of 35 cents per share. The results surpassed Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for a loss of 40 cents per share. The biotechnology company posted revenue of $13.5 million in the period, also exceeding Street forecasts. Four analysts surveyed by Zacks expected $12.7 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on OCUL at https://www.zacks.com/ap/OCUL

Investor releaseQuarter not tagged2026-08-03

Ocular Therapeutix™ Reports Second Quarter 2026 Financial Results and Business Highlights

GlobeNewswire
Ocular’s AXPAXLITM wet AMD NDA submission on track for Q4 2026 following positive Type C Meeting with the U.S. FDA in May 2026 FDA Type C Meeting Minutes Formalize SOL-1 Trial with Confirmatory Evidence as Sufficient to Support Submission of AXPAXLI NDA in wet AMD AXPAXLI NDA submission to be based on SOL-1 Week 52 efficacy and safety data, interim SOL-R safety data, and confirmatory evidence Pre-NDA meeting scheduled with FDA in Q3 2026 with the NDA submission to follow the Section 505(b)(2) pathway which could accelerate the review timeline by up to 60 days New Post Hoc SOL-1 analysis demonstrates up to an estimated 72% reduction in treatment burden over 60 weeks with AXPAXLI as compared to a projected on-label aflibercept (2 mg) dosing schedule of every 8 weeks Commercial readiness accelerating ahead of a potential 2027 launch Cash balance of $598.6 million as of June 30, 2026, with expected runway into 2028 BEDFORD, Mass., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today reported financial results for the second quarter ended June 30, 2026, and provided recent business highlights focused on its NDA submission plan and further clinical development for AXPAXLI (also known as OTX-TKI). The Company will not be hosting a second quarter 2026 conference call following its recent investor day in June. The Company plans to resume quarterly earnings calls for its third quarter 2026 financial results. “We continue to execute with discipline, precision, and urgency to redefine the retina experience and make AXPAXLI available to patients as early as possible. Our June Investor Day marked a pivotal milestone with the announcement of a clear, FDA-aligned path to submit the AXPAXLI NDA for wet AMD in the fourth quarter of 2026,” said Pravin U. Dugel, MD, Executive Chairman, President and CEO of Ocular Therapeutix. “This approach is designed to support the fastest risk-mitigated path to NDA submission and review. Consistent with the FDA Type C meeting minutes, the AXPAXLI NDA submission will be based on SOL-1 efficacy and safety data, interim safety data from SOL-R and supporting confirmatory evidence, including axitinib’s established profile as a VEGFR inhibitor from more than a decade of clinical use since FDA approval for renal cell carcinom…Read full document

Ocular’s AXPAXLITM wet AMD NDA submission on track for Q4 2026 following positive Type C Meeting with the U.S. FDA in May 2026 FDA Type C Meeting Minutes Formalize SOL-1 Trial with Confirmatory Evidence as Sufficient to Support Submission of AXPAXLI NDA in wet AMD AXPAXLI NDA submission to be based on SOL-1 Week 52 efficacy and safety data, interim SOL-R safety data, and confirmatory evidence Pre-NDA meeting scheduled with FDA in Q3 2026 with the NDA submission to follow the Section 505(b)(2) pathway which could accelerate the review timeline by up to 60 days New Post Hoc SOL-1 analysis demonstrates up to an estimated 72% reduction in treatment burden over 60 weeks with AXPAXLI as compared to a projected on-label aflibercept (2 mg) dosing schedule of every 8 weeks Commercial readiness accelerating ahead of a potential 2027 launch Cash balance of $598.6 million as of June 30, 2026, with expected runway into 2028 BEDFORD, Mass., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today reported financial results for the second quarter ended June 30, 2026, and provided recent business highlights focused on its NDA submission plan and further clinical development for AXPAXLI (also known as OTX-TKI). The Company will not be hosting a second quarter 2026 conference call following its recent investor day in June. The Company plans to resume quarterly earnings calls for its third quarter 2026 financial results. “We continue to execute with discipline, precision, and urgency to redefine the retina experience and make AXPAXLI available to patients as early as possible. Our June Investor Day marked a pivotal milestone with the announcement of a clear, FDA-aligned path to submit the AXPAXLI NDA for wet AMD in the fourth quarter of 2026,” said Pravin U. Dugel, MD, Executive Chairman, President and CEO of Ocular Therapeutix. “This approach is designed to support the fastest risk-mitigated path to NDA submission and review. Consistent with the FDA Type C meeting minutes, the AXPAXLI NDA submission will be based on SOL-1 efficacy and safety data, interim safety data from SOL-R and supporting confirmatory evidence, including axitinib’s established profile as a VEGFR inhibitor from more than a decade of clinical use since FDA approval for renal cell carcinoma. By pursuing the 505(b)(2) regulatory pathway, we believe the AXPAXLI NDA submission is strongly positioned to benefit from a review timeline up to 60 days shorter than the typical new molecular entity.” Peter K. Kaiser, MD, Chief Development Officer of Ocular Therapeutix added, “SOL-1 is the first and only successful superiority trial of a novel agent against an approved anti-VEGF therapy since the class emerged two decades ago. Today, up to 40% of wet AMD patients discontinue therapy within the first year alone, largely attributable to the treatment burden and its impact on patients and caregivers. In a new post-hoc analysis of SOL-1 data applying the SOL-R rescue criteria of >5 ETDRS letter loss and ≥75 µm CSFT increase from baseline, we estimate a treatment burden reduction of up to 72% as compared to a projected on-label dosing regimen of aflibercept (2 mg) over 60 weeks. The robust potential of AXPAXLI to reduce treatment burden in the real-world may improve adherence and long-term outcomes for our patients.” *Methodology outlined below in “Recent Achievements and Upcoming Milestones” Recent Achievements and Upcoming Milestones: New Drug Application (NDA) submission for AXPAXLI in wet AMD planned for Q4 2026, with FDA alignment confirmed in May 2026 Type C meeting minutes. The NDA submission will be based on SOL-1 efficacy and safety data, an interim SOL-R safety analysis of patients who have reached Week 52 to be conducted in the fourth quarter of 2026, and confirmatory evidence. Together with the existing SOL-1 safety database, this interim SOL-R safety analysis will bring the aggregate safety dataset to more than 300 patients with at least one year of AXPAXLI safety data and in-line with FDA requirements. A pre-NDA meeting with the FDA is scheduled for the third quarter of 2026. Ocular intends to submit the NDA under the 505(b)(2) pathway, which could accelerate the review timeline by up to 60 days. Post-hoc Analysis of SOL-1 (Phase 3, wet AMD) demonstrates up to an estimated 72% reduction in treatment burden over 60 weeks with AXPAXLI relative to a projected on-label dosing regimen of aflibercept (2 mg) every 8 weeks. The proportion of SOL-1 patients who would have remained rescue-free under the SOL-R rescue criteria of >5 ETDRS letter loss and ≥75 µm CSFT increase from baseline was 66.5% at Week 52. Applying the observed mean rescue treatment rates in SOL-1 to the estimated 33.5% of subjects requiring rescue under the SOL-R criteria corresponded to an average of 0.95 aflibercept (2 mg) rescues per subject for all subjects in the AXPAXLI arm through Week 52 after a single AXPAXLI injection at baseline. The total estimated mean injection burden with AXPAXLI represents a 72% reduction counting from the first screening visit at Week -8 excluding loading doses and a 56% reduction when loading doses are included, as compared to a projected on-label dosing regimen of aflibercept (2 mg) with no rescues. SOL-R (Phase 3, wet AMD) to be amended to maximize AXPAXLI label potential following robust SOL-1 results and confirmation from FDA that SOL-R efficacy data is not required for the AXPAXLI NDA submission. With superiority demonstrated at Weeks 36 and 52 against a single injection of aflibercept (2 mg) in SOL-1, Ocular now plans to evaluate a new key secondary endpoint of superiority to aflibercept (8 mg) at Week 96 in SOL-R. Another secondary endpoint will evaluate prevention of fibrosis and atrophy relative to aflibercept (2 mg) at Week 96. To facilitate these evaluations, Ocular will extend the efficacy analysis and sponsor-masking in SOL-R until the end of study at Week 96. These outcomes, if positive, have the potential to establish AXPAXLI as a best-in-disease agent in wet AMD. Following these changes, topline SOL-R results are now expected in the first quarter of 2028. The trial's primary endpoint, non-inferiority of AXPAXLI to aflibercept (2 mg) at Week 56, remains unchanged. SOL-X (wet AMD) enrollment continues to accelerate, with the vast majority of trial investigators and eligible patients opting to participate in the open-label extension study. Subjects who have completed their two-year follow-up in either the SOL-1 or SOL-R trials are eligible to enroll in the three-year open-label extension study evaluating the long-term safety and outcomes of AXPAXLI dosed every 24 weeks. Ocular believes sustained VEGF suppression with AXPAXLI may reduce the incidence of fibrosis and atrophy in wet AMD, thereby improving long-term outcomes. The first subject enrolled in SOL-X in April 2026. Diabetic retinopathy program streamlined to prioritize HELIOS-3 (Phase 3, NPDR) as Ocular's potential single registrational trial. HELIOS-3 will now evaluate AXPAXLI dosed every 12 months (Q48W) versus sham with the trial size being reduced from 930 to 620 patients. The decision to amend the HELIOS-3 design was based on AXPAXLI’s observed durability of up to 12 months in SOL-1, HELIOS-1 data, and market research showing physician preference for once-yearly dosing. HELIOS-3 is designed to support a broad label in diabetic retinal disease, including patients with diabetic macular edema (DME). Commercial readiness activities, including market and payer research, advancing rapidly ahead of a potential 2027 launch of AXPAXLI, if approved. Following SOL-1's results, market research found that approximately 80% of retina specialists surveyed would likely use a product with AXPAXLI’s profile based on SOL-1 data alone, with more than 90% expected to adopt such a product within its first year, if approved. Physicians cited disease control, predictable dosing interval, and seamless fit within existing workflows as key drivers of anticipated use. Ocular's payer team has also engaged 100% of Tier 1 Medicare Advantage and commercial payers, who have indicated that a label demonstrating superior durability could command premium pricing. Second Quarter Ended June 30, 2026, Financial Results: Total cash and cash equivalents were $598.6 million as of June 30, 2026. Based on current plans and related estimates of anticipated cash inflows from DEXTENZA®, the Company believes that its current cash balance is sufficient to support its planned operating expenses, debt service obligations, and capital expenditure requirements into 2028. This cash projection factors in the completion of the SOL-1 trial and the continued execution of the SOL-R, the SOL-X and the HELIOS-3 trials. The projection also includes investment in pre-commercial activities and preparations for the potential FDA approval and initial launch of AXPAXLI but does not currently include the full expenses the Company anticipates it needs to support the near-term commercialization of AXPAXLI, if approved. Total net revenue was $13.5 million for the second quarter of 2026, flat as compared to the comparable quarter of 2025. Total net revenue includes both gross DEXTENZA product revenue, net of discounts, rebates, and returns, which increased $0.1 million or 0.6% over Q2 2025, and collaboration revenue, which was $0.0 million in Q2 2026 versus $0.1 million in Q2 2025. Research and development expenses for the second quarter of 2026 were $54.1 million versus $51.1 million for the comparable quarter in 2025, reflecting an increase in overall clinical expenses associated with the ongoing SOL-1, SOL-R, SOL-X and HELIOS-3 clinical trials, with additional personnel and professional services to support these clinical trials and preparations to submit the planned NDA for AXPAXLI in wet AMD. Selling and marketing expenses were $17.3 million for the second quarter of 2026, as compared to $13.7 million for the comparable quarter of 2025, reflecting an increase in personnel-related costs, including stock-based compensation expense, related to the expansion of our commercial team and pre-commercial investments to support a potential AXPAXLI launch. General and administrative expenses were $22.2 million for the second quarter of 2026, as compared to $14.3 million for the comparable quarter of 2025, reflecting an increase in personnel-related costs, including stock-based compensation expense, professional fees and facility-related costs. Net loss for the second quarter of 2026 was $(78.8) million, or a net loss of $(0.35) per share on both a basic and diluted basis, compared to a net loss of $(67.8) million, or a net loss of $(0.39) per share on a basic and diluted basis, for the comparable quarter of 2025. Outstanding shares as of July 31, 2026, were approximately 225.0 million. About AXPAXLIAXPAXLI™ (also known as OTX-TKI) is an investigational, bioresorbable, intravitreal hydrogel incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD and diabetic retinal disease. About the SOL-1 TrialThe registrational Phase 3 SOL-1 trial (NCT06223958) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (1:1), parallel group trial that involves more than 100 clinical trial sites located in the U.S. and Argentina. In December 2024, the trial completed randomization of 344 treatment-naïve subjects with a diagnosis of wet AMD in the study eye. Two randomized subjects withdrew from the trial prior to receiving Day 1 treatment. The superiority trial has an eight-week loading segment prior to randomization. During the loading segment, subjects who have 20/80 vision or better and a central subfield thickness (CSFT) of ≤500 μm receive two doses of aflibercept (2 mg) at Week -8 and Week -4. Subjects who achieve best corrected visual acuity (BCVA) of 20/20 at Day 1 (baseline) or gain at least 10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at Day 1 along with a CSFT of ≤350 μm were then randomized to receive a single dose of AXPAXLI (0.45 mg) or a single dose of aflibercept (2 mg). At Week 52 and at Week 76, all subjects are re-dosed with their respective initial treatment of AXPAXLI (0.45 mg) or aflibercept (2 mg). Subjects will be followed for safety until the end of Week 104. Throughout the trial, subjects are assessed monthly. Trial subjects and designated trial personnel will remain masked through the end of Week 104. The clinical trial protocol requires that, during the trial, subjects in either arm meeting the pre-specified rescue criteria, which include a BCVA loss of ≥15 ETDRS letters from baseline or new vision-threatening macular hemorrhage, will receive a supplemental dose of aflibercept (2 mg). The protocol provides that after the first rescue injection, rescue therapy may be provided at investigator discretion per their clinical judgement. The primary endpoint of SOL-1 is the proportion of subjects who maintain visual acuity, defined as a loss of <15 ETDRS letters of BCVA from baseline, at Week 36. Predefined statistical rules were applied to adjust for treatment discontinuation or deviation as per the pre-specified statistical analysis plan. The trial remained masked following Week 36 and subjects were evaluated for treatment durability at Week 52. The trial is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. In February 2026, Ocular reported positive SOL-1 Week 52 topline data. The superiority primary endpoint was met with 74.1% of subjects in the AXPAXLI (0.45 mg) arm maintaining vision at Week 36, a 17.5% risk difference (p=0.0006), compared to the aflibercept (2 mg) arm. A key secondary endpoint was met with 65.9% of subjects treated with AXPAXLI (0.45 mg) maintaining vision at Week 52, a 21.1% risk difference (p<0.0001), compared to the aflibercept (2 mg) arm. About the SOL-R TrialThe registrational Phase 3 SOL-R trial (NCT06495918) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (2:2:1), three-arm trial that includes sites located in the U.S., Argentina, India, and Australia in subjects who are treatment-naïve or were diagnosed with wet AMD in the study eye within about four months prior to enrollment. Further, to qualify for screening, a subject’s study eye must have had a BCVA ETDRS letter score of ≥34 (~20/200). In December 2025, the trial completed the randomization of 640 subjects. This non-inferiority trial reflects a patient enrichment strategy over the six months prior to randomization that includes three screening doses of any anti-VEGF therapy, excluding brolucizumab-dbll, and monitoring to exclude those subjects with early persistent fluid or significant retinal fluid fluctuations. Subjects who continue to meet eligibility, defined as a CSFT of ≤350 μm at Week -12 and Week –8, with ≤35 μm CSFT increase at Week -8 from the lowest CSFT at any prior visit, entered a run-in period and received two loading doses of aflibercept (2 mg) prior to Day 1. Subjects in the first arm receive a single dose of AXPAXLI (0.45 mg) at Day 1 and are re-dosed at Weeks 24, 48, and 72. Subjects in the second arm receive aflibercept (2 mg) on Day 1 and per label every eight weeks thereafter. Subjects in the third arm receive a single dose of aflibercept (8 mg) at Day 1 and are re-dosed at Weeks 24, 48, and 72, aligned with the AXPAXLI treatment arm for adequate masking. Subjects will be followed for safety until the end of Week 96. Throughout the trial, subjects are assessed monthly. Trial subjects and designated trial personnel will remain masked through the end of Week 96. Subjects in any arm that meet pre-specified rescue criteria will receive a supplemental dose of aflibercept (2 mg). The pre-specified rescue criteria include a >5-letter loss in visual acuity plus a ≥75 μm increase in CSFT. The primary endpoint of SOL-R is to demonstrate non-inferiority in mean BCVA change from baseline between the AXPAXLI and on-label aflibercept (2 mg) arms at Week 56. As per the protocol agreed to by the FDA, the non-inferiority margin for the lower bound is -4.5 letters of mean BCVA when compared to aflibercept (2 mg) dosed every eight weeks. In a written Type C response received in August 2024, and a subsequent written response received in December 2024, the FDA agreed that the SOL-R repeat dosing wet AMD trial, with a primary endpoint at Week 56, should be appropriate as an adequate and well-controlled trial in support of a potential New Drug Application and product label for wet AMD. The trial will remain masked to the Company following the primary endpoint Week 56 time point, as key secondary endpoints will be evaluated through Week 96. About the SOL-X TrialThe SOL-X trial (NCT07516132) is a multi-center, 36-month open-label extension trial designed to evaluate the long-term safety, efficacy, and disease modifying potential of AXPAXLI in wet AMD for subjects who have successfully completed their two-year safety follow-up visits in either the SOL-1 or SOL-R trials. The first subject enrolled in the study in April 2026. According to the trial design, all subjects will be given AXPAXLI every 24 weeks, starting at Day 1 (after completion of the Week 104 visit in SOL-1, or Week 96 visit in SOL-R), and again at Weeks 24, 48, 72, 96, and 120. Subjects are assessed at Week 4, Week 12, and then every 12 weeks thereafter. Additional visits can be conducted with supplemental anti-VEGF injection administered based on investigator discretion. The primary objectives of SOL-X are to evaluate the long-term safety of AXPAXLI; to explore long-term visual outcomes, including visual acuity and the incidence and/or progression of fibrosis and macular atrophy; and to evaluate the impact of delayed initiation of AXPAXLI in patients who initially were randomized to receive aflibercept in either SOL-1 or SOL-R. About the HELIOS-3 TrialThe registrational Phase 3 HELIOS-3 trial (NCT07235085) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (1:1) two-arm superiority trial. The trial is designed to enroll approximately 620 subjects with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME). The first patient was randomized in the HELIOS-3 trial in November 2025. Subjects in the first arm receive a single dose of AXPAXLI at Day 1 and are re-dosed at Week 48. Subjects in the second arm receive a sham injection at Day 1 and Week 48 aligned with the AXPAXLI treatment arm for adequate masking. Throughout the trial, subjects are assessed every 4 weeks from Day 1 through Week 56 and every other month thereafter through Week 96. The primary endpoint of HELIOS-3 is the ordinal diabetic retinopathy severity score (DRSS) 2-step change status at Week 56 from baseline (≥2-step improvement, ≥2-step worsening, less than 2-step change in either direction). About Wet AMDWet age-related macular degeneration (wet AMD) is a leading cause of severe, irreversible vision loss affecting approximately 14.8 million individuals globally and 1.8 million in the United States alone. Wet AMD causes vision loss due to abnormal new blood vessel growth and hyperpermeability and associated retinal vascularity in the macula, which is primarily stimulated by local upregulation of vascular endothelial growth factor (VEGF). Without prompt and continuous treatment to control this exudative activity, patients develop irreversible vision loss. With proper treatment, patients may maintain visual function for a period of time and may temporarily regain lost vision. Challenges with current therapies include pulsatile, repeated intraocular injections, treatment-related adverse events and up to 40% patient discontinuation within one year of initiating treatment with continued disease progression. Taken together, these factors lead to undertreatment and a lack of long-term vision improvement for patients. About Diabetic Retinal DiseaseDiabetic retinal disease is an increasingly prevalent global health concern, driven by the rapidly rising number of individuals diagnosed with diabetes each year. Diabetic retinopathy (DR) is the most common category of retinal diseases, affecting over an estimated 103 million people worldwide. DR is a progressive condition in which retinal blood vessels are damaged following a cascade of events triggered by chronically elevated levels of blood glucose. As many as half of all diabetic patients are expected to develop some form of DR in their lifetime. DR can progress from the non-proliferative (NPDR) stages to the proliferative (PDR) stage characterized by the growth of abnormal new blood vessels. Fewer than 1% of the 6.4 million NPDR patients in the U.S. receive treatment today, despite the availability of anti-VEGF therapies approved for the indication, largely due to the burden of frequent injections. Diabetic macular edema (DME) is also a leading cause of vision loss in the working-age population. DME, the result of an accumulation of fluid in the macula that can afflict patients with diabetes, can occur at any stage of DR. In patients with DME, blood vessels in the eyes leak and start to swell, which can cause vision loss or blindness. Anti-VEGF drugs are approved to treat DME, but these treatments typically require frequent intravitreal injections, placing a significant burden on patients and physicians alike. About Ocular Therapeutix, Inc.Ocular Therapeutix, Inc. is an integrated biopharmaceutical company committed to redefining the retina experience. AXPAXLI™ (also known as OTX-TKI), Ocular’s investigational product candidate for retinal disease, is an axitinib intravitreal hydrogel based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) and diabetic retinal disease, including non-proliferative diabetic retinopathy (NPDR). Ocular’s pipeline also leverages the ELUTYX technology in its commercial product DEXTENZA®, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients and ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged two years or older, and in its investigational product candidate OTX-TIC, which is a travoprost intracameral hydrogel that has completed a Phase 2 clinical trial for the treatment of open-angle glaucoma or ocular hypertension. Ocular is currently evaluating next steps for the OTX-TIC program. Follow the Company on its website, LinkedIn, or X. DEXTENZA® is a registered trademark of Ocular Therapeutix, Inc. The Ocular Therapeutix logo, AXPAXLI™, ELUTYX™, and Ocular Therapeutix™ are trademarks of Ocular Therapeutix, Inc. Forward-Looking StatementsThis press release contains forward-looking statements of the Company regarding its future expectations, plans, and prospects; statements regarding the development and regulatory status of the Company’s product candidate AXPAXLI (also known as OTX-TKI), including the Company’s intention to submit a new drug application for AXPAXLI for the treatment of wet AMD based on Week 52 efficacy and safety data from the Company’s SOL-1 Phase 3 clinical trial, Week 52 data from an interim safety analysis to be conducted in the Company’s SOL-R clinical trial, and confirmatory evidence, and planned amendments to the clinical trial protocols of the Company’s SOL-R and HELIOS-3 clinical trials; statements regarding the timing, design, enrollment, randomization, conduct and retention of subjects in the Company’s ongoing and planned clinical trials for AXPAXLI, including the SOL-1, SOL-R and SOL-X clinical trials for the treatment of wet AMD and the HELIOS-3 trial for non-proliferative diabetic retinopathy; statements regarding the commercial potential of AXPAXLI, including market research findings and potential pricing; statements regarding the timing of the availability of data from the SOL-R trial; statements regarding the potential commercialization of AXPAXLI, including statements regarding the potential pricing and label of AXPAXLI and the timing of a potential commercial launch of AXPAXLI, if approved; statements regarding the Company’s plans to leverage the Section 505(b)(2) pathway and its potential to accelerate the review timeline of the Company’s planned NDA submission; statements regarding the Company’s cash runway and the sufficiency of the Company’s cash resources; statements regarding the potential utility or adoption, if approved, of any of the Company’s product candidates, including AXPAXLI; and other statements containing the words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “designed”, “goal”, “may”, “might”, “plan”, “position”, “predict”, “project”, “target”, “potential”, “will”, “would”, “could”, “should”, “continue”, and similar expressions, all of which constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties regarding the initiation, design, timing, conduct and outcomes of the Company’s ongoing clinical trials, including the Company’s SOL-1 trial, SOL-R trial, HELIOS-3 trial, and SOL-X trial; the timing and costs involved in commercializing any product or product candidate that receives regulatory approval; the risk that the U.S. Food and Drug Administration, or FDA, will not agree with the Company’s interpretation of the written agreements under the Special Protocol Assessments for AXPAXLI, including for the SOL-1 trial, or of the minutes of the Company’s Type C meeting with the FDA; uncertainty as to whether the FDA will accept a new drug application for AXPAXLI on the basis of a single pivotal clinical trial, notwithstanding discussions the Company has had with the FDA regarding its planned NDA submission; uncertainty as to the minimum clinical data required to demonstrate the safety of a proposed product candidate such as AXPAXLI, even if the FDA recognizes that only one pivotal clinical trial may be required to demonstrate efficacy and accepts the Company’s NDA submission; the risk that even though the FDA has agreed with the overall design of the SOL-1 trial, the FDA may not find that the data generated by the trial and submitted by the Company are sufficient to demonstrate the safety and efficacy of AXPAXLI to the degree necessary to support marketing approval for wet AMD; the risk that the FDA might not agree to the Company’s design, protocol, and statistical analysis plan of any of its clinical trials for which the Company has not obtained a Special Protocol Assessment, including the SOL-R trial; the risk that the Company and the FDA may not agree on, or maintain agreement with respect to, the registrational pathway for any of its product candidates, including AXPAXLI; uncertainty as to whether the Company will be able to timely satisfy the FDA’s other requirements for regulatory approval of AXPAXLI, including the FDA’s Chemistry, Manufacturing and Control’s requirements, even if the Company can satisfy the FDA’s clinical requirements to demonstrate safety and efficacy; uncertainty as to whether the Company’s NDA will qualify for, or whether the FDA will agree to review the NDA, if accepted for filing, under the 505(b)(2) pathway, notwithstanding discussions the Company has had with the FDA regarding its planned regulatory pathway, and whether the 505(b)(2) pathway will provide any time-savings as compared to the traditional 505(b)(1) pathway; uncertainty as to what restrictions, if any, may be imposed on the label for AXPAXLI, if approved, pending the receipt of additional clinical data or otherwise; uncertainty as to whether the data from earlier clinical trials will be predictive of the data of later clinical trials, particularly later clinical trials that have a different design or utilize a different formulation than the earlier trials, whether preliminary or interim data from a clinical trial or post-hoc analyses of clinical data will be predictive of final data from such trial, or whether data from a clinical trial assessing a product candidate for one indication will be predictive of results in other indications; uncertainty as to the Company’s ability to retain regulatory approval of any product or product candidate that receives regulatory approval; uncertainty as to whether data from the Company’s SOL-X trial will demonstrate additional clinically meaningful, long-term benefits; uncertainties regarding the potential commercial advantages and/or position of the Company’s product candidates; uncertainty regarding the implementation and impact of most-favored-nation and other reference pricing regimes on the commercial potential of AXPAXLI, especially in markets outside the United States; availability of data from clinical trials and expectations for regulatory submissions and approvals; the Company’s scientific approach and general development progress; uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials; the Company’s existing indebtedness and the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default; and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this press release. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Investors & MediaOcular Therapeutix, Inc.Bill SlatteryVice President, Investor [email protected]

Investor releaseQuarter not tagged2026-06-24

Ocular Therapeutix (OCUL): Buy, Sell, or Hold Post Q1 Earnings?

StockStory
Over the past six months, Ocular Therapeutix’s shares (currently trading at $10.37) have posted a disappointing 18.5% loss, well below the S&P 500’s 7.8% gain. This was partly due to its softer quarterly results and might have investors contemplating their next move. Is now the time to buy Ocular Therapeutix, or should you be careful about including it in your portfolio? Check out our in-depth research report to see what our analysts have to say, it’s free. Even though the stock has become cheaper, we don’t have much confidence in Ocular Therapeutix. Here are three reasons we avoid OCUL, plus one stock we’d rather own. We at StockStory place the most emphasis on long-term growth, but within healthcare, a stretched historical view may miss recent innovations or disruptive industry trends. Ocular Therapeutix’s recent performance marks a sharp pivot from its five-year trend as its revenue has shown annualized declines of 6.7% over the last two years. Adjusted operating margin is a key measure of profitability. Think of it as net income (the bottom line) excluding the impact of non-recurring expenses, taxes, and interest on debt - metrics less connected to business fundamentals. Analyzing the trend in its profitability, Ocular Therapeutix’s adjusted operating margin decreased significantly over the last five years. This raises questions about the company’s expense base because its revenue growth should have given it leverage on its fixed costs, resulting in better economies of scale and profitability. Ocular Therapeutix’s performance was poor no matter how you look at it - it shows that costs were rising and it couldn’t pass them onto its customers. Its adjusted operating margin for the trailing 12 months was negative 575%. Free cash flow isn’t a prominently featured metric in company financials and earnings releases, but we think it’s telling because it accounts for all operating and capital expenses, making it tough to manipulate. Cash is king. As you can see below, Ocular Therapeutix’s margin dropped meaningfully over the last five years. Almost any movement in the wrong direction is undesirable because it is already burning cash. If the trend continues, it could signal it’s in the middle of a big investment cycle. Ocular Therapeutix’s free cash flow margin for the trailing 12 months was negative 463%. Ocular Therapeutix falls short of our quality standards.…Read full document

Over the past six months, Ocular Therapeutix’s shares (currently trading at $10.37) have posted a disappointing 18.5% loss, well below the S&P 500’s 7.8% gain. This was partly due to its softer quarterly results and might have investors contemplating their next move. Is now the time to buy Ocular Therapeutix, or should you be careful about including it in your portfolio? Check out our in-depth research report to see what our analysts have to say, it’s free. Even though the stock has become cheaper, we don’t have much confidence in Ocular Therapeutix. Here are three reasons we avoid OCUL, plus one stock we’d rather own. We at StockStory place the most emphasis on long-term growth, but within healthcare, a stretched historical view may miss recent innovations or disruptive industry trends. Ocular Therapeutix’s recent performance marks a sharp pivot from its five-year trend as its revenue has shown annualized declines of 6.7% over the last two years. Adjusted operating margin is a key measure of profitability. Think of it as net income (the bottom line) excluding the impact of non-recurring expenses, taxes, and interest on debt - metrics less connected to business fundamentals. Analyzing the trend in its profitability, Ocular Therapeutix’s adjusted operating margin decreased significantly over the last five years. This raises questions about the company’s expense base because its revenue growth should have given it leverage on its fixed costs, resulting in better economies of scale and profitability. Ocular Therapeutix’s performance was poor no matter how you look at it - it shows that costs were rising and it couldn’t pass them onto its customers. Its adjusted operating margin for the trailing 12 months was negative 575%. Free cash flow isn’t a prominently featured metric in company financials and earnings releases, but we think it’s telling because it accounts for all operating and capital expenses, making it tough to manipulate. Cash is king. As you can see below, Ocular Therapeutix’s margin dropped meaningfully over the last five years. Almost any movement in the wrong direction is undesirable because it is already burning cash. If the trend continues, it could signal it’s in the middle of a big investment cycle. Ocular Therapeutix’s free cash flow margin for the trailing 12 months was negative 463%. Ocular Therapeutix falls short of our quality standards. Following the recent decline, the stock trades at $10.37 per share (or a forward price-to-sales ratio of 42.4×). The market typically values companies like Ocular Therapeutix based on their anticipated profits for the next 12 months, but it expects the business to lose money. We also think the upside isn’t great compared to the potential downside here - there are more exciting stocks to buy. We’d suggest looking at a top digital advertising platform riding the creator economy. WHILE YOU’RE HERE: Top 9 Market-Beating Stocks. The best stocks don’t just beat the market once. They do it again. And again. Robust revenue growth, rising free cash flow, returns on capital that leave their competition in the dust. The market has already rewarded these businesses. But our AI platform says the party isn’t over. Find out which 9 stocks made the cut this week — FREE. Get Our Top 9 Market-Beating Stocks for Free HERE. Stocks that have made our list include now familiar names such as Nvidia (+1,326% between June 2020 and June 2025) as well as under-the-radar businesses like the once-micro-cap company Kadant (+351% five-year return). Find your next big winner with StockStory today.

Investor releaseQuarter not tagged2026-06-17

Ocular Therapeutix™ Investor Day to Highlight U.S. FDA Alignment on AXPAXLI™ NDA with Submission Planned for Fourth Quarter 2026

GlobeNewswire
Per May 2026 Type C meeting, AXPAXLI NDA for wet AMD to be based on SOL-1 Week 52 efficacy and safety plus interim SOL-R safety data Ocular to conduct interim SOL-R safety analysis in 4Q 2026 to reach >300 patients of safety data across SOL-1 and SOL-R, in alignment with FDA requirements Complete AXPAXLI NDA package in wet AMD planned to be submitted in 4Q 2026 SOL-R efficacy data no longer part of the AXPAXLI NDA submission plan Ocular will evaluate superiority of AXPAXLI vs aflibercept (8mg) Q6M at Week 96 as a key secondary endpoint of the SOL-R trial SOL-R to remain masked through Week 96, with topline results now expected in 1Q 2028 New secondary endpoint addition to SOL-R has the potential to establish AXPAXLI as a best-in-disease agent for wet AMD and further differentiate potential label to support broad global adoption, if approved In alignment with the FDA, Ocular plans to submit its NDA under the 505(b)(2) pathway, with potential to accelerate the review timeline by up to 60 days Following strong SOL-1 data, diabetic retinopathy program also streamlined to prioritize HELIOS-3 as a potential single registrational trial evaluating Q12M dosing of AXPAXLI The event will begin at 2:00 PM ET today in New York City with virtual access available BEDFORD, Mass., June 17, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, will host an Investor Day today to showcase its FDA-aligned plans to submit its NDA for AXPAXLI™ (also known as OTX-TKI) in wet AMD in the fourth quarter of 2026 based on SOL-1 efficacy and safety data together with interim SOL-R safety data. With SOL-R efficacy data no longer part of the planned AXPAXLI NDA submission, Ocular is amending the design of SOL-R and plans to extend masking to evaluate new secondary endpoints at Week 96 to show potential superiority in best corrected visual acuity (BCVA) over aflibercept (8 mg) and to support further differentiation from aflibercept (2 mg) in the potential label for AXPAXLI. Topline data for SOL-R are now expected during the first quarter of 2028. Ocular also plans to streamline its registrational program in non-proliferative diabetic retinopathy (NPDR) to prioritize a single Phase 3 trial, HELIOS-3. “Our consistently strong execution has brought us to a pivotal milestone today. We ar…Read full document

Per May 2026 Type C meeting, AXPAXLI NDA for wet AMD to be based on SOL-1 Week 52 efficacy and safety plus interim SOL-R safety data Ocular to conduct interim SOL-R safety analysis in 4Q 2026 to reach >300 patients of safety data across SOL-1 and SOL-R, in alignment with FDA requirements Complete AXPAXLI NDA package in wet AMD planned to be submitted in 4Q 2026 SOL-R efficacy data no longer part of the AXPAXLI NDA submission plan Ocular will evaluate superiority of AXPAXLI vs aflibercept (8mg) Q6M at Week 96 as a key secondary endpoint of the SOL-R trial SOL-R to remain masked through Week 96, with topline results now expected in 1Q 2028 New secondary endpoint addition to SOL-R has the potential to establish AXPAXLI as a best-in-disease agent for wet AMD and further differentiate potential label to support broad global adoption, if approved In alignment with the FDA, Ocular plans to submit its NDA under the 505(b)(2) pathway, with potential to accelerate the review timeline by up to 60 days Following strong SOL-1 data, diabetic retinopathy program also streamlined to prioritize HELIOS-3 as a potential single registrational trial evaluating Q12M dosing of AXPAXLI The event will begin at 2:00 PM ET today in New York City with virtual access available BEDFORD, Mass., June 17, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, will host an Investor Day today to showcase its FDA-aligned plans to submit its NDA for AXPAXLI™ (also known as OTX-TKI) in wet AMD in the fourth quarter of 2026 based on SOL-1 efficacy and safety data together with interim SOL-R safety data. With SOL-R efficacy data no longer part of the planned AXPAXLI NDA submission, Ocular is amending the design of SOL-R and plans to extend masking to evaluate new secondary endpoints at Week 96 to show potential superiority in best corrected visual acuity (BCVA) over aflibercept (8 mg) and to support further differentiation from aflibercept (2 mg) in the potential label for AXPAXLI. Topline data for SOL-R are now expected during the first quarter of 2028. Ocular also plans to streamline its registrational program in non-proliferative diabetic retinopathy (NPDR) to prioritize a single Phase 3 trial, HELIOS-3. “Our consistently strong execution has brought us to a pivotal milestone today. We are thrilled to announce that we have FDA alignment on our plans to submit the AXPAXLI NDA for wet AMD in the fourth quarter of 2026, based on SOL-1 efficacy and safety data, combined with interim safety data from SOL-R. This approach reflects our unwavering commitment to bring AXPAXLI to patients as quickly as possible while mitigating regulatory risk,” said Pravin U. Dugel, MD, Executive Chairman, President and CEO of Ocular Therapeutix. “The strength of the SOL-1 data speaks for itself. It is the first successful trial in wet AMD for a novel agent showing superiority over an approved anti-VEGF. The data for AXPAXLI from SOL-1 showed unmatched durability and a level of sustained disease control that is simply unprecedented in this space. Because of these outstanding data, and with SOL-R year one efficacy data no longer being part of our planned NDA submission, we are now in the extraordinary position of using the SOL-R trial to best serve our long-term strategic objective for AXPAXLI: to become the best-in-disease agent for wet AMD. We are now adding a new key secondary endpoint of superiority in mean change in BCVA compared to aflibercept (8 mg) in SOL-R which will be evaluated at Week 96, and we also hope to demonstrate the prevention of fibrosis and atrophy with AXPAXLI relative to aflibercept (2 mg) at this timepoint. Expanding on our confidence in AXPAXLI and based on the demonstration of up to 12 months of durability seen in SOL-1 and HELIOS-1, we have also made the strategic decision to streamline our diabetic retinopathy program to prioritize a single global registrational trial, HELIOS-3, evaluating Q12M AXPAXLI versus sham. Our market research shows retina specialists strongly favor a once-yearly regimen for rapid uptake in diabetic retinopathy, and HELIOS-3 also supports our global objectives. With FDA alignment regarding our NDA submission for wet AMD, planned for the fourth quarter of 2026, and our commercial readiness efforts advancing rapidly, we are well positioned to bring AXPAXLI to patients in 2027, if approved, not only as a potential best-in-class agent, but also as the first-in-class.” Lejla Vajzovic, MD, FASRS, Professor of Ophthalmology with Tenure at Duke University School of Medicine, added, “SOL-1 gives retina specialists everything we need to start using AXPAXLI immediately and broadly, if approved. The unmet need in wet AMD is not abstract – it is something we confront daily. Over 40% of patients discontinue or are non-adherent to treatment within the first year alone because the treatment burden can be simply unsustainable. Missed visits mean lost vision, and current therapies offer no cushion for the realities of patients’ lives. AXPAXLI has the potential to provide that cushion. What retina specialists have been searching for is a therapy that can provide sustained disease control without requiring constant retreatment, and the SOL-1 data suggest AXPAXLI may finally deliver that. The results demonstrated clinically meaningful durability, robust anatomical control, and vision outcomes that were maintained through one year with substantially fewer interventions than we are accustomed to seeing in clinical practice. Ocular’s commitment to bringing AXPAXLI to patients as quickly as possible is clear, and that urgency is exactly what these patients deserve.” Investor Day Highlights Wet Age-Related Macular Degeneration (wet AMD) Program Highlights During May 2026 Type C Meeting, Ocular reached alignment with U.S. FDA to submit AXPAXLI New Drug Application (NDA) in wet AMD based on SOL-1 data plus confirmatory evidence under the 505(b)(2) pathway. SOL-1 constitutes an adequate and well-controlled study, as previously aligned through a Special Protocol Assessment (SPA) agreement, with a p-value for its primary endpoint (p=0.0006) that is highly supportive of a single trial approval. Based on its Type C Meeting with the FDA, Ocular plans to submit its NDA under the 505(b)(2) pathway. The 505(b)(2) pathway can accelerate the review timeline for new formulations, dosages, routes of administration, or indications of previously approved drugs by up to 60 days. FDA indicates it will review the NDA submission based on a single pivotal trial in light of results from SOL-1 at Week 52. SOL-1 demonstrated superiority on the pre-specified primary endpoint of maintenance of vision at Week 36, with strengthening effect size over time, consistent visual outcomes, and supportive anatomic benefits, which together create a highly persuasive data package around substantial evidence of efficacy. All six pre-specified sensitivity analyses for the SOL-1 primary endpoint at Week 36 were statistically significant, and the first three of five hierarchically controlled key secondary endpoints were also met with statistical significance. Ocular plans to support its NDA submission for AXPAXLI with broad confirmatory evidence. The U.S. FDA defines confirmatory evidence in its September 2023 draft guidance for industry titled “Demonstrating Substantial Evidence of Effectiveness with One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence”. The AXPAXLI NDA is expected to be supported by strong confirmatory evidence, including mechanistic, pharmacodynamic, animal model, natural history, class consistency, and real-world evidence. To meet FDA requirements for safety exposure, Ocular plans to conduct an interim safety analysis for SOL-R in fourth quarter of 2026. The U.S. FDA notes that one trial may establish effectiveness but still requires adequate safety exposure, defined in the 2023 guidance for neovascular AMD trials as a minimum of 300 patients at the time of NDA submission. With 170 subjects receiving AXPAXLI in SOL-1, Ocular plans to conduct an interim safety analysis of patients completing one year in SOL-R during the fourth quarter of 2026 to reach an aggregate of greater than 300 patients with at least one year of treatment across SOL-1 and SOL-R. Because of the interim analysis, SOL-R will incur a 0.0001 alpha penalty during its statistical analysis. Ocular plans to hold a pre-NDA meeting in third quarter of 2026 with U.S. FDA. The meeting is intended to confirm the format and content of information to be submitted in the NDA and to ensure the FDA has exactly what it needs to review the drug for marketing approval. The Company expects to submit a complete NDA package in fourth quarter of 2026. At the standard 120-day safety update following the submission of its NDA, Ocular plans to submit Year 2 SOL-1 safety data to the FDA to support repeat dosing on a potential label for AXPAXLI, if approved. Because SOL-R efficacy is no longer part of the planned NDA submission or review, Ocular intends to leverage the trial to best serve its long-term strategic objectives for AXPAXLI. This includes maintaining masking of SOL-R to subjects, investigators, and the Company until Week 96 to evaluate new secondary endpoints, with topline data now expected in first quarter of 2028. “The regulatory framework for single-trial approval requires an adequate and well-controlled study, a protocol that is aligned with the FDA, the primary endpoint to be met with high statistical significance, clinically meaningful results, a robust safety dataset, and supporting confirmatory evidence,” commented Arshad M. Khanani, MD, MA, FASRS, Director of Clinical Research at Sierra Eye Associates in Reno, Nevada, and Steering Committee Chair for the SOL Program. “SOL-1 trial results potentially meet this high bar of a single trial approval with the combined data from the planned SOL-R interim analysis providing the required >300 patients for the safety dataset. SOL-1 was aligned with the FDA through its SPA agreement in advance, met its primary endpoint with a p-value of 0.0006, showed clinically meaningful visual outcomes with durability up to one year with robust anatomic benefit to match, and a well-tolerated safety profile. Each criterion independently is compelling, and collectively they provide an incredibly strong regulatory package. If approved, AXPAXLI has the potential to significantly reduce treatment burden and optimize long-term vision outcomes for our patients with wet AMD.” Diabetic Retinopathy (DR) Program Highlights Ocular announced plans to streamline its diabetic retinopathy (DR) program to prioritize a single global registrational superiority study, HELIOS-3. Based on the strength of the SOL-1 and prior HELIOS-1 data, along with emerging market research indicating strong physician preference for a once-yearly treatment paradigm in DR, the Company plans to advance a streamlined superiority trial evaluating AXPAXLI Q12M versus sham. In HELIOS-3, non-proliferative diabetic retinopathy (NPDR) subjects will receive either AXPAXLI or sham injections at randomization and Week 48. The primary endpoint for HELIOS-3, an ordinal ≥2-step change in diabetic retinopathy severity score (DRSS), will be measured at Week 56. The Company expects the streamlined approach to preserve its ability to achieve global regulatory objectives and maximize the commercial opportunity for AXPAXLI in diabetic retinal disease. The trial is intended to support a broad DR label, including patients with non-center-involved diabetic macular edema (non-CI DME). Click here to register for Ocular’s Investor Day which will begin at 2:00 PM ET today. A live webcast of the presentation will be available on the “Events and Presentations” section of the Company’s website. A replay of the webcast will be archived for at least 30 days following the presentation. About AXPAXLIAXPAXLI™ (also known as OTX-TKI) is an investigational, bioresorbable, intravitreal hydrogel incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD and diabetic retinal disease. About the SOL-1 TrialThe registrational Phase 3 SOL-1 trial (NCT06223958) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (1:1), parallel group trial that involves more than 100 clinical trial sites located in the U.S. and Argentina. In December 2024, the trial completed randomization of 344 treatment-naïve subjects with a diagnosis of wet AMD in the study eye. Two randomized subjects withdrew from the trial prior to receiving Day 1 treatment. The superiority trial has an eight-week loading segment prior to randomization. During the loading segment, subjects who have 20/80 vision or better and a central subfield thickness (CSFT) of ≤500 μm receive two doses of aflibercept (2 mg) at Week -8 and Week -4. Subjects who achieve best corrected visual acuity (BCVA) of 20/20 at Day 1 (baseline) or gain at least 10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at Day 1 along with a CSFT of ≤350 μm were then randomized to receive a single dose of AXPAXLI (0.45 mg) or a single dose of aflibercept (2 mg). At Week 52 and at Week 76, all subjects are re-dosed with their respective initial treatment of AXPAXLI (0.45 mg) or aflibercept (2 mg). Subjects will be followed for safety until the end of Week 104. Throughout the trial, subjects are assessed monthly. Trial subjects and designated trial personnel will remain masked through the end of Week 104. The clinical trial protocol requires that, during the trial, subjects in either arm meeting the pre-specified rescue criteria, which include a BCVA loss of ≥15 ETDRS letters from baseline or new vision-threatening macular hemorrhage, will receive a supplemental dose of aflibercept (2 mg). The protocol provides that after the first rescue injection, rescue therapy may be provided at investigator discretion per their clinical judgement. The primary endpoint of SOL-1 is the proportion of subjects who maintain visual acuity, defined as a loss of <15 ETDRS letters of BCVA from baseline, at Week 36. Predefined statistical rules were applied to adjust for treatment discontinuation or deviation as per the pre-specified statistical analysis plan. The trial remained masked following Week 36 and subjects were evaluated for treatment durability at Week 52. The trial is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. In February 2026, Ocular reported positive SOL-1 Week 52 topline data. The superiority primary endpoint was met with 74.1% of subjects in the AXPAXLI (0.45 mg) arm maintaining vision at Week 36, a 17.5% risk difference (p=0.0006), compared to the aflibercept (2 mg) arm. A key secondary endpoint was met with 65.9% of subjects treated with AXPAXLI (0.45 mg) maintaining vision at Week 52, a 21.1% risk difference (p<0.0001), compared to the aflibercept (2 mg) arm. About the SOL-R TrialThe registrational Phase 3 SOL-R trial (NCT06495918) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (2:2:1), three-arm trial that includes sites located in the U.S., Argentina, India, and Australia in subjects who are treatment-naïve or were diagnosed with wet AMD in the study eye within about four months prior to enrollment. Further, to qualify for screening, a subject’s study eye must have had a BCVA ETDRS letter score of ≥34 (~20/200). In December 2025, the trial completed the randomization of 631 subjects. This non-inferiority trial reflects a patient enrichment strategy over the six months prior to randomization that includes three screening doses of any anti-VEGF therapy, excluding brolucizumab-dbll, and monitoring to exclude those subjects with early persistent fluid or significant retinal fluid fluctuations. Subjects who continue to meet eligibility, defined as a CSFT of ≤350 μm at Week -12 and Week -8 with ≤35 μm CSFT increase from the lowest CSFT at any prior visit, entered a run-in period and received two loading doses of aflibercept (2 mg) prior to Day 1. Subjects in the first arm receive a single dose of AXPAXLI (0.45 mg) at Day 1 and are re-dosed at Weeks 24, 48, and 72. Subjects in the second arm receive aflibercept (2 mg) on Day 1 and per label every eight weeks thereafter. Subjects in the third arm receive a single dose of aflibercept (8 mg) at Day 1 and are re-dosed at Weeks 24, 48, and 72, aligned with the AXPAXLI treatment arm for adequate masking. Subjects will be followed for safety until the end of Week 96. Throughout the trial, subjects are assessed monthly. Trial subjects and designated trial personnel will remain masked through the end of Week 96. Subjects in any arm that meet pre-specified rescue criteria will receive a supplemental dose of aflibercept (2 mg). The pre-specified rescue criteria include a >5-letter loss in visual acuity plus a ≥75 μm increase in CSFT. The primary endpoint of SOL-R is to demonstrate non-inferiority in mean BCVA change from baseline between the AXPAXLI and on-label aflibercept (2 mg) arms at Week 56. As per the protocol agreed to by the FDA, the non-inferiority margin for the lower bound is -4.5 letters of mean BCVA when compared to aflibercept (2 mg) dosed every eight weeks. In a written Type C response received in August 2024, and a subsequent written response received in December 2024, the FDA agreed that the SOL-R repeat dosing wet AMD trial, with a primary endpoint at Week 56, should be appropriate as an adequate and well-controlled trial in support of a potential New Drug Application and product label for wet AMD. The trial will remain masked to the Company following the primary endpoint Week 56 time point, as key secondary endpoints will be evaluated through Week 96. About the HELIOS-3 TrialThe registrational Phase 3 HELIOS-3 trial (NCT07235085) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (1:1) two-arm superiority trial. The trial is designed to enroll approximately 620 subjects with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME). The first patient was randomized in the HELIOS-3 trial in November 2025. Subjects in the first arm receive a single dose of AXPAXLI at Day 1 and are re-dosed at Week 48. Subjects in the second arm receive a sham injection at Day 1 and Week 48 aligned with the AXPAXLI treatment arm for adequate masking. Throughout the trial, subjects are assessed every 4 weeks from Day 1 through Week 56 and every other month thereafter through Week 96. The primary endpoint of HELIOS-3 is the ordinal diabetic retinopathy severity score (DRSS) 2-step change status at Week 56 from baseline (≥2-step improvement, ≥2-step worsening, less than 2-step change in either direction). About Wet AMDWet age-related macular degeneration (wet AMD) is a leading cause of severe, irreversible vision loss affecting approximately 14.8 million individuals globally and 1.7 million in the United States alone. Wet AMD causes vision loss due to abnormal new blood vessel growth and hyperpermeability and associated retinal vascularity in the macula, which is primarily stimulated by local upregulation of vascular endothelial growth factor (VEGF). Without prompt and continuous treatment to control this exudative activity, patients develop irreversible vision loss. With proper treatment, patients may maintain visual function for a period of time and may temporarily regain lost vision. Challenges with current therapies include pulsatile, repeated intraocular injections, treatment-related adverse events and up to 40% patient discontinuation within one year of initiating treatment with continued disease progression. Taken together, these factors lead to undertreatment and a lack of long-term vision improvement for patients. About Diabetic Retinal DiseaseDiabetic retinal disease is an increasingly prevalent global health concern, driven by the rapidly rising number of individuals diagnosed with diabetes each year. Diabetic retinopathy (DR) is the most common category of retinal diseases, affecting over an estimated 103 million people worldwide. DR is a progressive condition in which retinal blood vessels are damaged following a cascade of events triggered by chronically elevated levels of blood glucose. As many as half of all diabetic patients are expected to develop some form of DR in their lifetime. DR can progress from the non-proliferative (NPDR) stages to the proliferative (PDR) stage characterized by the growth of abnormal new blood vessels. Fewer than 1% of the 6.4 million NPDR patients in the U.S. receive treatment today, despite the availability of anti-VEGF therapies approved for the indication, largely due to the burden of frequent injections. Diabetic macular edema (DME) is also a leading cause of vision loss in the working-age population. DME, the result of an accumulation of fluid in the macula that can afflict patients with diabetes, can occur at any stage of DR. In patients with DME, blood vessels in the eyes leak and start to swell, which can cause vision loss or blindness. Anti-VEGF drugs are approved to treat DME, but these treatments typically require frequent intravitreal injections, placing a significant burden on patients and physicians alike. About Ocular Therapeutix, Inc.Ocular Therapeutix, Inc. is an integrated biopharmaceutical company committed to redefining the retina experience. AXPAXLI™ (also known as OTX-TKI), Ocular’s investigational product candidate for retinal disease, is an axitinib intravitreal hydrogel based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) and diabetic retinal disease, including non-proliferative diabetic retinopathy (NPDR). Ocular’s pipeline also leverages the ELUTYX technology in its commercial product DEXTENZA®, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients and ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged two years or older, and in its investigational product candidate OTX-TIC, which is a travoprost intracameral hydrogel that has completed a Phase 2 clinical trial for the treatment of open-angle glaucoma or ocular hypertension. Ocular is currently evaluating next steps for the OTX-TIC program. Follow the Company on its website, LinkedIn, or X. DEXTENZA® is a registered trademark of Ocular Therapeutix, Inc. The Ocular Therapeutix logo, AXPAXLI™, ELUTYX™, and Ocular Therapeutix™ are trademarks of Ocular Therapeutix, Inc. Forward-Looking StatementsThis press release contains forward-looking statements of the Company regarding its future expectations, plans, and prospects; statements regarding the development and regulatory status of the Company’s product candidate AXPAXLI (also known as OTX-TKI), including the Company’s intention to submit a new drug application for AXPAXLI for the treatment of wet AMD based on Week 52 efficacy and safety data from the Company’s SOL-1 Phase 3 clinical trial and Week 52 data from an interim safety analysis to be conducted in the Company’s SOL-R clinical trial and planned amendments to the clinical trial protocols of the Company’s SOL-R and HELIOS-3 clinical trials; statements regarding the timing, design, enrollment, randomization, conduct and retention of subjects in the Company’s ongoing and planned clinical trials for AXPAXLI, including the SOL-1 and SOL-R Phase 3 clinical trials for the treatment of wet AMD and the HELIOS-3 trial for non-proliferative diabetic retinopathy; statements regarding the commercial potential of AXPAXLI; statements regarding the timing of the availability of data from the SOL-R trial; statements regarding the potential commercialization of AXPAXLI, including statements regarding the potential label of AXPAXLI, if approved; statements regarding the Company’s cash runway and the sufficiency of the Company’s cash resources; statements regarding the potential utility or adoption, if approved, of any of the Company’s product candidates, including AXPAXLI; and other statements containing the words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “designed”, “goal”, “may”, “might”, “plan”, “position”, “predict”, “project”, “target”, “potential”, “will”, “would”, “could”, “should”, “continue”, and similar expressions, all of which constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties regarding the initiation, design, timing, conduct and outcomes of the Company’s ongoing clinical trials, including the Company’s SOL-1 trial, SOL-R trial, HELIOS-3 trial, and SOL-X trial; the timing and costs involved in commercializing any product or product candidate that receives regulatory approval; the risk that the U.S. Food and Drug Administration, or FDA, will not agree with the Company’s interpretation of the written agreements under the Special Protocol Assessments for AXPAXLI, including for the SOL-1 trial; uncertainty as to whether the FDA will accept a new drug application for AXPAXLI on the basis of a single pivotal clinical trial, notwithstanding discussions the Company has had with the FDA regarding its planned NDA submission; uncertainty as to the minimum clinical data required to demonstrate the safety of a proposed product candidate such as AXPAXLI, even if the FDA recognizes that only one pivotal clinical trial may be required to demonstrate efficacy; the risk that even though the FDA has agreed with the overall design of the SOL-1 trial, the FDA may not find that the data generated by the trial and submitted by the Company are sufficient to demonstrate the safety and efficacy of AXPAXLI to the degree necessary to support marketing approval for wet AMD; the risk that the FDA might not agree to the Company’s design, protocol, and statistical analysis plan of any of its clinical trials for which the Company has not obtained a Special Protocol Assessment, including the SOL-R trial; the risk that the Company and the FDA may not agree on, or maintain agreement with respect to, the registrational pathway for any of its product candidates, including AXPAXLI; uncertainty as to whether the Company will be able to timely satisfy the FDA’s other requirements for regulatory approval of AXPAXLI, including the FDA’s Chemistry, Manufacturing and Control’s requirements, even if the Company can satisfy the FDA’s clinical requirements to demonstrate safety and efficacy; uncertainty as to whether the Company’s NDA will qualify for, or whether the FDA will agree to review the NDA, if accepted for filing, under the 505(b)(2) pathway, notwithstanding discussions the Company has had with the FDA regarding its planned regulatory pathway, and whether the 505(b)(2) pathway will provide any time-savings as compared to the traditional 505(b)(1) pathway; uncertainty as to what restrictions, if any, may be imposed on the label for AXPAXLI, if approved, pending the receipt of additional clinical data or otherwise; uncertainty as to whether the data from earlier clinical trials will be predictive of the data of later clinical trials, particularly later clinical trials that have a different design or utilize a different formulation than the earlier trials, whether preliminary or interim data from a clinical trial will be predictive of final data from such trial, or whether data from a clinical trial assessing a product candidate for one indication will be predictive of results in other indications; uncertainty as to the Company’s ability to retain regulatory approval of any product or product candidate that receives regulatory approval; uncertainty as to whether data from the Company’s SOL-X trial will demonstrate additional clinically meaningful, long-term benefits; uncertainties regarding the potential commercial advantages and/or position of the Company’s product candidates; uncertainty regarding the implementation and impact of most-favored-nation and other reference pricing regimes on the commercial potential of AXPAXLI, especially in markets outside the United States; availability of data from clinical trials and expectations for regulatory submissions and approvals; the Company’s scientific approach and general development progress; uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials; the Company’s existing indebtedness and the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default; and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this press release. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Investors & MediaOcular Therapeutix, Inc.Bill SlatteryVice President, Investor [email protected]

Investor releaseQuarter not tagged2026-05-06

Ocular Therapeutix Q1 Earnings Call Highlights

MarketBeat
AXPAXLI’s Phase 3 SOL-1 trial showed statistical superiority to aflibercept (p=0.0006) and durable disease control, with about two‑thirds of patients maintaining vision for a year after a single injection and a substantially delayed need for rescue treatment versus aflibercept. NDA planning is underway based on SOL-1 week‑52 data using a 505(b)(2) pathway, while SOL‑R (631 randomized, non‑inferiority) remains on track with top‑line data now expected in Q1 2027 and SOL‑X (long‑term extension) has begun enrollment. Ocular is accelerating commercial readiness—positioning AXPAXLI as a possible six‑month fixed‑dosing option—and ended Q1 with approximately $667 million in cash, which management says should fund the company into 2028 (excluding full commercialization expenses). Interested in Ocular Therapeutix, Inc.? Here are five stocks we like better. Ocular Therapeutix (NASDAQ:OCUL) management used its first-quarter 2026 earnings call to highlight clinical and regulatory progress for AXPAXLI, the company’s investigational therapy for wet age-related macular degeneration (wet AMD), while also outlining next steps for its broader retinal disease pipeline and commercialization planning. Executive Chairman, President, and CEO Dr. Pravin Dugel said the company believes the Phase 3 SOL-1 trial “fundamentally changed the conversation in wet AMD,” emphasizing that AXPAXLI was “the first novel investigational therapy to demonstrate superiority to an approved anti-VEGF agent in a phase III wet AMD trial.” Dugel highlighted statistical strength for the primary endpoint, citing a p-value of 0.0006. → Roblox Stock Slides to New Low as Safety Changes Weigh on Outlook Dugel said the company sees the clinical significance as equally important, pointing to what he described as durability and disease control with fewer rescue treatments. He said that “in two-thirds of the patients, just a single AXPAXLI injection maintained vision for an entire year.” He also described a meaningfully delayed time to first rescue versus aflibercept, stating that the rescue rate in the aflibercept arm at week 28 “was not reached in the AXPAXLI arm until six months later at week 52.” In discussing additional analyses presented at The Macula Society and the Vit-Buckle Society annual meeting, Dugel cited data on time to fluid volume increases. He said subjects treated with AXPAXLI took “about 5–6 mont…Read full document

AXPAXLI’s Phase 3 SOL-1 trial showed statistical superiority to aflibercept (p=0.0006) and durable disease control, with about two‑thirds of patients maintaining vision for a year after a single injection and a substantially delayed need for rescue treatment versus aflibercept. NDA planning is underway based on SOL-1 week‑52 data using a 505(b)(2) pathway, while SOL‑R (631 randomized, non‑inferiority) remains on track with top‑line data now expected in Q1 2027 and SOL‑X (long‑term extension) has begun enrollment. Ocular is accelerating commercial readiness—positioning AXPAXLI as a possible six‑month fixed‑dosing option—and ended Q1 with approximately $667 million in cash, which management says should fund the company into 2028 (excluding full commercialization expenses). Interested in Ocular Therapeutix, Inc.? Here are five stocks we like better. Ocular Therapeutix (NASDAQ:OCUL) management used its first-quarter 2026 earnings call to highlight clinical and regulatory progress for AXPAXLI, the company’s investigational therapy for wet age-related macular degeneration (wet AMD), while also outlining next steps for its broader retinal disease pipeline and commercialization planning. Executive Chairman, President, and CEO Dr. Pravin Dugel said the company believes the Phase 3 SOL-1 trial “fundamentally changed the conversation in wet AMD,” emphasizing that AXPAXLI was “the first novel investigational therapy to demonstrate superiority to an approved anti-VEGF agent in a phase III wet AMD trial.” Dugel highlighted statistical strength for the primary endpoint, citing a p-value of 0.0006. → Roblox Stock Slides to New Low as Safety Changes Weigh on Outlook Dugel said the company sees the clinical significance as equally important, pointing to what he described as durability and disease control with fewer rescue treatments. He said that “in two-thirds of the patients, just a single AXPAXLI injection maintained vision for an entire year.” He also described a meaningfully delayed time to first rescue versus aflibercept, stating that the rescue rate in the aflibercept arm at week 28 “was not reached in the AXPAXLI arm until six months later at week 52.” In discussing additional analyses presented at The Macula Society and the Vit-Buckle Society annual meeting, Dugel cited data on time to fluid volume increases. He said subjects treated with AXPAXLI took “about 5–6 months longer” to reach certain fluid thresholds compared with aflibercept, which he framed as a marker of sustained anatomic disease control. → The Real SpaceX Play: 5 Chip Stocks Powering the IPO Before It Launches Dugel said AXPAXLI was well-tolerated in SOL-1 and that the company has been “extremely transparent” regarding safety. He told investors the company provided subject-level details in medical meeting presentations and reported that it did not observe “a single treatment-related serious ocular or systemic adverse event such as endophthalmitis or vasculitis.” Management said it remains on track to submit a New Drug Application based on SOL-1 week 52 data, “subject to ongoing formal discussions with the U.S. FDA.” Dugel noted that the FDA has publicly discussed moving toward a single registrational trial as a default option for approvals and said Ocular believes SOL-1 “checks all the boxes,” including having a Special Protocol Assessment (SPA). He added that the company intends to use the 505(b)(2) pathway and said it may allow for a shortened review timeline. → 3 Emerging Markets ETFs to Maximize Exposure to High-Potential Countries During Q&A, analysts repeatedly asked for more detail on the timing and content of FDA interactions, including whether a pre-NDA meeting had occurred. Dugel said the company is “not in the habit of disclosing the details of our FDA meetings,” but described the discussions as “ongoing,” “formal,” and “collaborative.” When asked about scenarios where the company might file with SOL-1 versus waiting for SOL-R, he said Ocular had not disclosed timelines and would update investors “when appropriate.” For SOL-R, Dugel said Ocular completed randomization of 631 subjects in December 2025, exceeding the original 555-subject target. Due to swift enrollment, the company accelerated guidance for SOL-R top-line data to the first quarter of 2027. Dugel described SOL-R as a non-inferiority trial designed to complement SOL-1 and said the study includes a 24-week screening and loading phase before randomization intended to screen out high fluid fluctuations. He said retention is strong and site engagement remains high. Ocular also announced initiation of enrollment in SOL-X, an open-label long-term extension study in wet AMD. Dugel said SOL-X will follow subjects who have completed two-year follow-up in SOL-1 or SOL-R for an additional three years, for total follow-up of five years. He said the crossover design—where subjects initially treated with aflibercept transition to AXPAXLI—could help evaluate whether delaying AXPAXLI affects long-term outcomes such as fibrosis and atrophy, which he associated with “pulsatile VEGF suppression.” Dugel said the company is accelerating commercial readiness “in parallel,” including building infrastructure, engaging payers, and refining its commercial strategy. Chief Operating Officer Donald Notman, Chief Strategy Officer Sanjay Nayak, and Chief Commercial Officer Steve Meyers joined Dugel for the Q&A portion, though Dugel answered the questions in the transcript provided. Asked about how retina specialists might integrate AXPAXLI based on SOL-1, Dugel said discussions are ongoing and offered his view that AXPAXLI could become an “every six months, fixed dosing drug.” He said some physicians might move directly to fixed dosing while others could start with a treat-and-extend approach before transitioning as confidence builds. Dugel also argued that adoption could be seamless because “nothing changes for the doctor,” pointing to a self-sealing 25-gauge needle and no new equipment requirements. Beyond wet AMD, Dugel said the HELIOS-3 trial in diabetic retinopathy remains ongoing and described it as a superiority study intended to support a broad label across diabetic retinal disease. He said HELIOS-3 allows enrollment of patients with non-central involved diabetic macular edema (DME), reflecting a continuum of disease. In response to a question about enrollment proportions for non-central involved DME, Dugel said there was no such requirement that the company had guided to. He added that Ocular believes it will not need another diabetic retinopathy study to cover diabetic retinal disease broadly, while also noting it is “far too early” for FDA labeling discussions. Ocular announced it will host an Investor Day on June 17 in New York City. Dugel said the company plans to provide regulatory updates regarding the NDA submission plan in wet AMD, detailed updates on SOL-R and SOL-X, diabetic retinopathy program updates, and “a first look” at its planned commercialization strategy for AXPAXLI. He said the event will also feature retinal key opinion leaders discussing SOL-1, expectations for SOL-R, and the evolving wet AMD treatment landscape. On the financial front, Dugel said Ocular ended the first quarter with approximately $667 million in cash, which management expects will provide runway into 2028. He added that the runway estimate does not include the full expenses anticipated to support commercialization of AXPAXLI. Ocular Therapeutix, Inc is a biopharmaceutical company dedicated to the development of innovative therapies for diseases and conditions of the eye. Founded in 2011 and headquartered in Bedford, Massachusetts, the company focuses on sustained-release drug delivery platforms designed to address key unmet needs in ophthalmology. Its proprietary hydrogel-based inserts and sealants aim to improve patient compliance and outcomes by providing controlled release of active pharmaceutical ingredients directly to ocular tissues. The company's flagship product, DEXTENZA®, is a preservative-free, sustained-release dexamethasone intracanalicular insert approved by the U.S. The article "Ocular Therapeutix Q1 Earnings Call Highlights" was originally published by MarketBeat.

Investor releaseQuarter not tagged2026-05-05

Ocular Therapeutix: Q1 Earnings Snapshot

Associated Press

BEDFORD, Mass. (AP) — BEDFORD, Mass. (AP) — Ocular Therapeutix Inc. (OCUL) on Tuesday reported a loss of $88.6 million in its first quarter. The Bedford, Massachusetts-based company said it had a loss of 40 cents per share. Losses, adjusted for non-recurring gains, were 41 cents per share. The results missed Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was for a loss of 32 cents per share. The biotechnology company posted revenue of $10.8 million in the period, which also missed Street forecasts. Four analysts surveyed by Zacks expected $12.7 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on OCUL at https://www.zacks.com/ap/OCUL

Investor releaseQuarter not tagged2026-05-05

Ocular Therapeutix (NASDAQ:OCUL) Reports Sales Below Analyst Estimates In Q1 CY2026 Earnings

StockStory
Ophthalmology biopharmaceutical company Ocular Therapeutix (NASDAQ:OCUL) missed Wall Street’s revenue expectations in Q1 CY2026, with sales flat year on year at $10.79 million. Its GAAP loss of $0.40 per share was 20.5% below analysts’ consensus estimates. Is now the time to buy Ocular Therapeutix? Find out in our full research report. Revenue: $10.79 million vs analyst estimates of $12.92 million (flat year on year, 16.5% miss) EPS (GAAP): -$0.40 vs analyst expectations of -$0.33 (20.5% miss) Adjusted Operating Income: -$93.34 million vs analyst estimates of -$75.37 million (-865% margin, 23.8% miss) Operating Margin: -865%, down from -597% in the same quarter last year Market Capitalization: $2.13 billion “2026 is off to a tremendous start for Ocular, driven by the superiority demonstrated with AXPAXLI in the landmark SOL-1 Phase 3 trial in wet AMD,” said Pravin U. Dugel, MD, Executive Chairman, President and CEO of Ocular Therapeutix. Pioneering a drug delivery platform that can eliminate the need for monthly eye injections, Ocular Therapeutix (NASDAQ:OCUL) develops sustained-release treatments for eye diseases using its proprietary ELUTYX bioresorbable hydrogel technology that gradually releases medication. A company’s long-term sales performance can indicate its overall quality. Even a bad business can shine for one or two quarters, but a top-tier one grows for years. Over the last five years, Ocular Therapeutix grew its sales at an impressive 19.8% compounded annual growth rate. Its growth beat the average healthcare company and shows its offerings resonate with customers. We at StockStory place the most emphasis on long-term growth, but within healthcare, a half-decade historical view may miss recent innovations or disruptive industry trends. Ocular Therapeutix’s recent performance marks a sharp pivot from its five-year trend as its revenue has shown annualized declines of 6.7% over the last two years. This quarter, Ocular Therapeutix’s $10.79 million of revenue was flat year on year, falling short of Wall Street’s estimates. Looking ahead, sell-side analysts expect revenue to grow 14.5% over the next 12 months, an improvement versus the last two years. This projection is noteworthy and suggests its newer products and services will catalyze better top-line performance. ONE MORE THING: The $21 AI Application Stock Wall Street Forgot. While Wall Street…Read full document

Ophthalmology biopharmaceutical company Ocular Therapeutix (NASDAQ:OCUL) missed Wall Street’s revenue expectations in Q1 CY2026, with sales flat year on year at $10.79 million. Its GAAP loss of $0.40 per share was 20.5% below analysts’ consensus estimates. Is now the time to buy Ocular Therapeutix? Find out in our full research report. Revenue: $10.79 million vs analyst estimates of $12.92 million (flat year on year, 16.5% miss) EPS (GAAP): -$0.40 vs analyst expectations of -$0.33 (20.5% miss) Adjusted Operating Income: -$93.34 million vs analyst estimates of -$75.37 million (-865% margin, 23.8% miss) Operating Margin: -865%, down from -597% in the same quarter last year Market Capitalization: $2.13 billion “2026 is off to a tremendous start for Ocular, driven by the superiority demonstrated with AXPAXLI in the landmark SOL-1 Phase 3 trial in wet AMD,” said Pravin U. Dugel, MD, Executive Chairman, President and CEO of Ocular Therapeutix. Pioneering a drug delivery platform that can eliminate the need for monthly eye injections, Ocular Therapeutix (NASDAQ:OCUL) develops sustained-release treatments for eye diseases using its proprietary ELUTYX bioresorbable hydrogel technology that gradually releases medication. A company’s long-term sales performance can indicate its overall quality. Even a bad business can shine for one or two quarters, but a top-tier one grows for years. Over the last five years, Ocular Therapeutix grew its sales at an impressive 19.8% compounded annual growth rate. Its growth beat the average healthcare company and shows its offerings resonate with customers. We at StockStory place the most emphasis on long-term growth, but within healthcare, a half-decade historical view may miss recent innovations or disruptive industry trends. Ocular Therapeutix’s recent performance marks a sharp pivot from its five-year trend as its revenue has shown annualized declines of 6.7% over the last two years. This quarter, Ocular Therapeutix’s $10.79 million of revenue was flat year on year, falling short of Wall Street’s estimates. Looking ahead, sell-side analysts expect revenue to grow 14.5% over the next 12 months, an improvement versus the last two years. This projection is noteworthy and suggests its newer products and services will catalyze better top-line performance. ONE MORE THING: The $21 AI Application Stock Wall Street Forgot. While Wall Street obsesses over who’s building AI, one company is already using it to print money. And nobody’s paying attention. AI chip stocks trade at ridiculous valuations. This company processes a trillion consumer signals monthly using AI and trades at a third of the price. The gap won’t last. The institutions will figure it out. You need to see this first. Read the FREE Report Before They Notice. Ocular Therapeutix’s high expenses have contributed to an average adjusted operating margin of negative 277% over the last five years. Unprofitable healthcare companies require extra attention because they could get caught swimming naked when the tide goes out. It’s hard to trust that the business can endure a full cycle. Looking at the trend in its profitability, Ocular Therapeutix’s adjusted operating margin decreased significantly over the last five years. The company’s two-year trajectory also shows it failed to get its profitability back to the peak as its margin fell by 422.6 percentage points. This performance was poor no matter how you look at it - it shows its expenses were rising and it couldn’t pass those costs onto its customers. In Q1, Ocular Therapeutix generated a negative 865% adjusted operating margin. We track the long-term change in earnings per share (EPS) for the same reason as long-term revenue growth. Compared to revenue, however, EPS highlights whether a company’s growth is profitable. Although Ocular Therapeutix’s full-year earnings are still negative, it reduced its losses and improved its EPS by 6% annually over the last five years. The next few quarters will be critical for assessing its long-term profitability. In Q1, Ocular Therapeutix reported EPS of negative $0.40, down from negative $0.38 in the same quarter last year. This print missed analysts’ estimates. Over the next 12 months, Wall Street expects Ocular Therapeutix to improve its earnings losses. Analysts forecast its full-year EPS of negative $1.46 will advance to negative $1.39. We struggled to find many positives in these results. Its revenue missed and its EPS fell short of Wall Street’s estimates. Overall, this was a weaker quarter. The stock remained flat at $9.69 immediately after reporting. Ocular Therapeutix may have had a tough quarter, but does that actually create an opportunity to invest right now? The latest quarter does matter, but not nearly as much as longer-term fundamentals and valuation, when deciding if the stock is a buy. We cover that in our actionable full research report which you can read here, it’s free.

Investor releaseQuarter not tagged2026-05-05

Ocular Therapeutix™ Reports First Quarter 2026 Financial Results and Business Highlights

GlobeNewswire
Enrollment underway in SOL-X long-term extension trial in wet AMD for subjects completing two-year follow-up in SOL-1 or SOL-R Announced positive Phase 3 SOL-1 results in February 2026, first ever successful wet AMD superiority trial comparing a novel investigative agent to an approved anti-VEGF SOL-1 Week 52 data presentations held at Macula Society and VBS meetings reinforce AXPAXLI’s unmatched durability and sustained disease control data in wet AMD Commercial preparedness plans accelerated as Ocular intends to submit AXPAXLI NDA based on SOL-1 Week 52 data, subject to ongoing formal discussions with the U.S. FDA SOL-R Phase 3 non-inferiority trial in wet AMD on track for topline readout in 1Q 2027 HELIOS-3 Phase 3 trial in diabetic retinopathy ongoing Ocular to host Investor Day on Wednesday, June 17, 2026, in New York City, including key program and regulatory updates Cash balance of $666.7 million as of March 31, 2026, with expected runway into 2028 BEDFORD, Mass., May 05, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today reported financial results for the first quarter ended March 31, 2026, and provided recent business highlights. “2026 is off to a tremendous start for Ocular, driven by the superiority demonstrated with AXPAXLI in the landmark SOL-1 Phase 3 trial in wet AMD,” said Pravin U. Dugel, MD, Executive Chairman, President and CEO of Ocular Therapeutix. “AXPAXLI delivered highly statistically significant, consistent, and superior outcomes with substantially fewer rescues compared to a single dose of aflibercept (2 mg) in SOL-1. The trial not only met a high bar for clinical success, but it also defined a clear, differentiated, and compelling product profile, with data showing unmatched durability combined with a level of sustained disease control that is exceptional. The strength of these data has generated overwhelming enthusiasm across the retina community and reinforces our belief that AXPAXLI has the potential to fundamentally change how wet AMD is treated. We look forward to submitting our NDA based on SOL-1 Week 52 data, subject to our ongoing formal discussions with the U.S. FDA, and are rapidly advancing our commercial readiness efforts.” Dr. Dugel continued, “Beyond SOL-1, the recent initiation of enrollment in our SO…Read full document

Enrollment underway in SOL-X long-term extension trial in wet AMD for subjects completing two-year follow-up in SOL-1 or SOL-R Announced positive Phase 3 SOL-1 results in February 2026, first ever successful wet AMD superiority trial comparing a novel investigative agent to an approved anti-VEGF SOL-1 Week 52 data presentations held at Macula Society and VBS meetings reinforce AXPAXLI’s unmatched durability and sustained disease control data in wet AMD Commercial preparedness plans accelerated as Ocular intends to submit AXPAXLI NDA based on SOL-1 Week 52 data, subject to ongoing formal discussions with the U.S. FDA SOL-R Phase 3 non-inferiority trial in wet AMD on track for topline readout in 1Q 2027 HELIOS-3 Phase 3 trial in diabetic retinopathy ongoing Ocular to host Investor Day on Wednesday, June 17, 2026, in New York City, including key program and regulatory updates Cash balance of $666.7 million as of March 31, 2026, with expected runway into 2028 BEDFORD, Mass., May 05, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today reported financial results for the first quarter ended March 31, 2026, and provided recent business highlights. “2026 is off to a tremendous start for Ocular, driven by the superiority demonstrated with AXPAXLI in the landmark SOL-1 Phase 3 trial in wet AMD,” said Pravin U. Dugel, MD, Executive Chairman, President and CEO of Ocular Therapeutix. “AXPAXLI delivered highly statistically significant, consistent, and superior outcomes with substantially fewer rescues compared to a single dose of aflibercept (2 mg) in SOL-1. The trial not only met a high bar for clinical success, but it also defined a clear, differentiated, and compelling product profile, with data showing unmatched durability combined with a level of sustained disease control that is exceptional. The strength of these data has generated overwhelming enthusiasm across the retina community and reinforces our belief that AXPAXLI has the potential to fundamentally change how wet AMD is treated. We look forward to submitting our NDA based on SOL-1 Week 52 data, subject to our ongoing formal discussions with the U.S. FDA, and are rapidly advancing our commercial readiness efforts.” Dr. Dugel continued, “Beyond SOL-1, the recent initiation of enrollment in our SOL-X wet AMD extension trial marks another important milestone and underscores the exceptional execution we are delivering across the AXPAXLI program. Along those lines, SOL-R is progressing expeditiously, with topline data on track for the first quarter of 2027, while HELIOS-3 also remains ongoing. At our upcoming Investor Day on June 17, we look forward to providing further updates on our ongoing trials, key regulatory updates, and our accelerated commercial plans for AXPAXLI. With a strong balance sheet and increasing momentum across the organization, we are well positioned to advance AXPAXLI toward potential approval and to achieve our bold mission of redefining the retina experience.” Recent Achievements and Upcoming Milestones: SOL-X (wet AMD) open label extension trial enrollment initiated in April 2026. Subjects who have completed two-year safety follow-up in either SOL-1 or SOL-R are eligible to enroll in the SOL-X trial for an additional three years of safety follow-up. SOL-X outcomes may further expand AXPAXLI’s potential by highlighting the need to start AXPAXLI treatment early or potentially risk worse long-term visual outcomes due to potential fibrosis and atrophy that may be seen with pulsatile treatments. By potentially reducing the treatment burden and improving long-term outcomes, Ocular believes the data from SOL-X could support increased treatment adherence over both the short- and long-terms, thereby expanding the market opportunity substantially. SOL-1 (Phase 3, wet AMD) positive results announced in February 2026 highlight AXPAXLI’s unmatched durability in wet AMD with sustained disease control. The SOL-1 superiority trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Having successfully met the primary endpoint in SOL-1, AXPAXLI is the first ever novel investigative agent to successfully demonstrate superiority to a single dose of an approved anti-VEGF. With a highly statistically significant primary endpoint (p=0.0006), SOL-1 has the potential to support the first label with a superiority claim over an anti-VEGF. Brief highlights from the SOL-1 data include: Superior Visual Outcomes: With just a single AXPAXLI injection, 74.1% of AXPAXLI-treated subjects maintained vision (as defined by the clinical trial protocol) at Week 36, and 65.9% maintained vision to Week 52 compared to 55.8% at Week 36 and 44.2% at Week 52 in the aflibercept (2 mg) arm. Superior Anatomic Control: Post hoc analyses demonstrated that 55.9% of AXPAXLI-treated subjects maintained CSFT increase within 30 μm from baseline at Week 36, with 44.1% maintaining this level of control up to Week 52 compared to 37.8% at Week 36 and 34.9% at Week 52 in the aflibercept (2 mg) arm. Well Tolerated Safety Profile: AXPAXLI was generally well-tolerated, with no observed treatment-related ocular or systemic serious adverse events. SOL-1 results through Week 52 were first presented at the 49th Macula Society Annual Meeting on February 27, 2026. Additional Week 52 data, including post-hoc analyses, were presented at the 14th Annual Vit-Buckle Society (VBS) Meeting on April 11, 2026. Copies of these releases and presentations are available in the Investors section of the Company’s website. AXPAXLI New Drug Application (NDA) submission for wet AMD remains on track based on the SOL-1 Week 52 trial results, subject to ongoing formal discussions with the U.S. FDA. Ocular plans to leverage the 505(b)(2) application pathway, which could potentially shorten the NDA review timeline for AXPAXLI by up to two months. The Company plans to provide regulatory updates during its Investor Day on June 17, 2026. SOL-R (Phase 3, wet AMD) non-inferiority trial remains on track for topline data in 1Q 2027. The SOL-R trial completed randomization of 631 subjects in December 2025, exceeding Ocular’s 555-subject target. This non-inferiority trial complements SOL-1 with the potential to provide additional data to support the rapid adoption of AXPAXLI into clinical practice, if approved. SOL-R incorporates a comprehensive 24-week screening and loading phase to exclude subjects with early persistent fluid or significant retinal fluid fluctuations, thereby de-risking the randomized trial population. HELIOS-3 (Phase 3, NPDR) trial ongoing as Ocular plans to provide an update on its diabetic retinopathy program at June Investor Day. HELIOS-3 is a superiority trial in subjects with moderately severe or severe non-proliferative diabetic retinopathy (NPDR). The trial is designed to support a broad label in diabetic retinal disease by allowing subjects with non-center-involved diabetic macular edema (non-CI-DME) to be enrolled in the trial. The Company plans to provide a program update at its June 2026 Investor Day. Investor Day to be held on Wednesday, June 17, 2026, in New York City. The event will feature presentations from senior Company leadership and panel discussions with prominent retinal disease Key Opinion Leaders (KOLs). Key areas of focus include regulatory updates regarding the AXPAXLI NDA submission plan in wet AMD, and the registrational program for AXPAXLI in diabetic retinopathy. The Company also plans to provide an update on the ongoing SOL-R and SOL-X trials in wet AMD, and the commercialization strategy for AXPAXLI in wet AMD, if approved. Additional event details will be provided in advance. To register for Ocular’s 2026 Investor Day, please visit the Investor section of Ocular’s website or register HERE. First Quarter Ended March 31, 2026, Financial Results: Total cash and cash equivalents were $666.7 million as of March 31, 2026. Based on current plans and related estimates of anticipated cash inflows from DEXTENZA®, the Company believes that its current cash balance is sufficient to support its planned expenses, debt service obligations, and capital expenditure requirements into 2028. This cash projection factors in the completion of the SOL-1 trial, the expected topline data readout from the SOL-R trial, continuation of the SOL-X wet AMD open label extension trial and the HELIOS-3, and if needed, HELIOS-2 registrational trials in NPDR, plus investment in pre-commercial activities associated with AXPAXLI, but does not currently include the full expenses the Company anticipates it needs to support the commercialization of AXPAXLI, if approved. Total net revenue was $10.8 million for the first quarter of 2026, a 0.8% increase as compared to total net revenue of $10.7 million in the comparable quarter in 2025. Total net revenue includes both gross DEXTENZA product revenue, net of discounts, rebates, and returns, which the Company refers to as net product revenue, and collaboration revenue. Research and development expenses for the first quarter of 2026 were $66.2 million versus $42.9 million for the comparable quarter in 2025, reflecting an increase in overall clinical expenses associated with the ongoing SOL-1, SOL-R, and HELIOS-3 Phase 3 clinical trials, and recent initiation of the SOL-X trial, with additional personnel and professional services to support these clinical trials. Selling and marketing expenses were $16.6 million for the first quarter of 2026, as compared to $14.1 million for the comparable quarter of 2025, primarily reflecting an increase in personnel-related costs, including stock-based compensation expense, related to the expansion of our commercial team and pre-commercial activities for AXPAXLI. General and administrative expenses were $20.0 million for the first quarter of 2026, as compared to $16.3 million for the comparable quarter of 2025, primarily due to an increase in personnel-related costs, including stock-based compensation expense, professional fees and facility-related costs. Net loss for the first quarter of 2026 was $(88.6) million, or a net loss of $(0.40) per share on both a basic and diluted basis, compared to a net loss of $(64.1) million, or a net loss of $(0.38) per share on a basic and diluted basis, for the comparable quarter of 2025. The net loss in the first quarter of 2026 includes a net gain from the change in fair value of our derivative liability of $1.5 million, which is comprised of a non-cash gain from fair value measurement of the derivative liability associated with the Barings Credit Facility of $1.8 million, and expense related to actual royalty fees under the Barings Credit Facility of $(0.4) million. The net loss for the first quarter of 2025 includes a net loss from the change in the fair value of our derivative liability of $(1.0) million, which is comprised of a $(0.6) million non-cash loss from fair value measurement of the derivative liability associated with the Barings Credit Facility, and expense related to actual royalty fees of $(0.4) million under the Barings Credit Facility. Outstanding shares as of May 1, 2026, were approximately 219.0 million. Conference Call and Webcast Information: Ocular Therapeutix will host a conference call and webcast on Tuesday, May 5, 2026, at 8:00 AM ET to discuss recent business progress and financial results for the first quarter ended March 31, 2026. To access the call, please dial: 1-800-343-4136 (U.S.) or 1-203-518-9843 (International). The live webcast can be accessed HERE (Conference ID: OCULAR) and the live and archived webcast can also be accessed by visiting the Ocular Therapeutix website on the Events and Presentations section of the Investor Relations page. A replay of the webcast will be archived for at least 30 days. About AXPAXLI AXPAXLI™ (also known as OTX-TKI) is an investigational, bioresorbable, intravitreal hydrogel incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD and diabetic retinal disease. About the SOL-1 Trial The registrational Phase 3 SOL-1 trial (NCT06223958) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (1:1), parallel group trial that involves more than 100 clinical trial sites located in the U.S. and Argentina. In December 2024, the trial completed randomization of 344 treatment-naïve subjects with a diagnosis of wet AMD in the study eye. Two randomized subjects withdrew from the trial prior to receiving Day 1 treatment. The superiority trial has an eight-week loading segment prior to randomization. During the loading segment, subjects who have 20/80 vision or better and a central subfield thickness (CSFT) of ≤500 μm receive two doses of aflibercept (2 mg) at Week -8 and Week -4. Subjects who achieve best corrected visual acuity (BCVA) of 20/20 at Day 1 (baseline) or gain at least 10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at Day 1 along with a CSFT of ≤350 μm were then randomized to receive a single dose of AXPAXLI (0.45 mg) or a single dose of aflibercept (2 mg). At Week 52 and at Week 76, all subjects are re-dosed with their respective initial treatment of AXPAXLI (0.45 mg) or aflibercept (2 mg). Subjects will be followed for safety until the end of Week 104. Throughout the trial, subjects are assessed monthly. Trial subjects and designated trial personnel will remain masked through the end of Week 104. The clinical trial protocol requires that, during the trial, subjects in either arm meeting the pre-specified rescue criteria, which includes a BCVA loss of ≥15 ETDRS letters from baseline or new vision-threatening macular hemorrhage, will receive a supplemental dose of aflibercept (2 mg). The protocol provides that after the first rescue injection, rescue therapy may be provided at investigator discretion per their clinical judgement. The primary endpoint of SOL-1 is the proportion of subjects who maintain visual acuity, defined as a loss of <15 ETDRS letters of BCVA from baseline, at Week 36. Predefined statistical rules were applied to adjust for treatment discontinuation or deviation as per the pre-specified statistical analysis plan. The trial remained masked following Week 36 and subjects were evaluated for treatment durability at Week 52. The trial is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. In February 2026, Ocular reported positive SOL-1 Week 52 topline data. The superiority primary endpoint was met with 74.1% of subjects in the AXPAXLI (0.45 mg) arm maintaining vision at Week 36, a 17.5% risk difference (p=0.0006), compared to the aflibercept (2 mg) arm. A key secondary endpoint was met with 65.9% of subjects treated with AXPAXLI (0.45 mg) maintaining vision at Week 52, a 21.1% risk difference (p<0.0001), compared to the aflibercept (2 mg) arm. About the SOL-R Trial The registrational Phase 3 SOL-R trial (NCT06495918) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (2:2:1), three-arm trial that includes sites located in the U.S., Argentina, India, and Australia in subjects who are treatment-naïve or were diagnosed with wet AMD in the study eye within about four months prior to enrollment. Further, to qualify for screening, a subject’s study eye must have had a BCVA ETDRS letter score of ≥34 (~20/200). In December 2025, the trial completed the randomization of 631 subjects. This non-inferiority trial reflects a patient enrichment strategy over the six months prior to randomization that includes three screening doses of any anti-VEGF therapy, excluding brolucizumab-dbll, and monitoring to exclude those subjects with early persistent fluid or significant retinal fluid fluctuations. Subjects who continue to meet eligibility, defined as a CSFT of ≤350 μm at Week -12 and Week -8 with ≤35 μm CSFT increase from the lowest CSFT at any prior visit, entered a run-in period and received two loading doses of aflibercept (2 mg) prior to Day 1. Subjects in the first arm receive a single dose of AXPAXLI (0.45 mg) at Day 1 and are re-dosed at Weeks 24, 48, and 72. Subjects in the second arm receive aflibercept (2 mg) on Day 1 and per label every eight weeks thereafter. Subjects in the third arm receive a single dose of aflibercept (8 mg) at Day 1 and are re-dosed at Weeks 24, 48, and 72, aligned with the AXPAXLI treatment arm for adequate masking. Subjects will be followed for safety until the end of Week 96. Throughout the trial, subjects are assessed monthly. Trial subjects and designated trial personnel will remain masked through the end of Week 96. Subjects in any arm that meet pre-specified rescue criteria will receive a supplemental dose of aflibercept (2 mg). The pre-specified rescue criteria include a >5-letter loss in visual acuity plus a ≥75 μm increase in CSFT. The primary endpoint of SOL-R is to demonstrate non-inferiority in mean BCVA change from baseline between the AXPAXLI and on-label aflibercept (2 mg) arms at Week 56. As per the protocol agreed to by the FDA, the non-inferiority margin for the lower bound is -4.5 letters of mean BCVA when compared to aflibercept (2 mg) dosed every eight weeks. In a written Type C response received in August 2024, and a subsequent written response received in December 2024, the FDA agreed that the SOL-R repeat dosing wet AMD trial, with a primary endpoint at Week 56, should be appropriate as an adequate and well-controlled trial in support of a potential New Drug Application and product label for wet AMD. About the SOL-X Trial The SOL-X trial (NCT07516132) is a multi-center, 36-month open-label extension trial designed to evaluate the long-term safety, efficacy, and disease modifying potential of AXPAXLI in wet AMD for subjects who have successfully completed their two-year safety follow-up visits in either the SOL-1 or SOL-R trials. The first subject enrolled in the study in April 2026. According to the trial design, all subjects will be given AXPAXLI every 24 weeks, starting at Day 1 (after completion of the Week 104 visit in SOL-1, or Week 96 visit in SOL-R), and again at Weeks 24, 48, 72, 96, and 120. Subjects are assessed at Week 4, Week 12, and then every 12 weeks thereafter. Additional visits can be conducted with supplemental anti-VEGF injection administered based on investigator discretion. The primary objectives of SOL-X are to evaluate the long-term safety of AXPAXLI; to explore long-term visual outcomes, including visual acuity and the incidence and/or progression of fibrosis and macular atrophy; and to evaluate the impact of delayed initiation of AXPAXLI in patients who initially were randomized to receive aflibercept in either SOL-1 or SOL-R. About the HELIOS-3 Trial The registrational Phase 3 HELIOS-3 trial (NCT07235085) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (1:1:1), three-arm superiority trial. The trial is designed to enroll approximately 930 subjects with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME). The first patient was randomized in the HELIOS-3 trial in November 2025. Subjects in the first arm receive a single dose of AXPAXLI at Day 1 and are re-dosed at Weeks 24, 48 and 72. Subjects in the second arm receive a single dose of AXPAXLI at Day 1 and Week 48 and sham injection at Weeks 24 and 72. Subjects in the third arm receive sham injection at Day 1 and at Weeks 24, 48 and 72 aligned with the AXPAXLI treatment arms for adequate masking. Throughout the trial, subjects are assessed every 4 weeks from Day 1 through Week 56 and every other month thereafter through Week 96. The primary endpoint of HELIOS-3 is the ordinal diabetic retinopathy severity score (DRSS) 2-step change status at Week 56 from baseline (≥2-step improvement, ≥2-step worsening, less than 2-step change in either direction). About Wet AMD Wet age-related macular degeneration (wet AMD) is a leading cause of severe, irreversible vision loss affecting approximately 14.8 million individuals globally and 1.7 million in the United States alone. Wet AMD causes vision loss due to abnormal new blood vessel growth and hyperpermeability and associated retinal vascularity in the macula, which is primarily stimulated by local upregulation of vascular endothelial growth factor (VEGF). Without prompt and continuous treatment to control this exudative activity, patients develop irreversible vision loss. With proper treatment, patients may maintain visual function for a period of time and may temporarily regain lost vision. Challenges with current therapies include pulsatile, repeated intraocular injections, treatment-related adverse events and up to 40% patient discontinuation within one year of initiating treatment with continued disease progression. Taken together, these factors lead to undertreatment and a lack of long-term vision improvement for patients. About Diabetic Retinal Disease Diabetic retinal disease is an increasingly prevalent global health concern, driven by the rapidly rising number of individuals diagnosed with diabetes each year. Diabetic retinopathy (DR) is the most common category of retinal diseases, affecting over an estimated 103 million people worldwide. DR is a progressive condition in which retinal blood vessels are damaged following a cascade of events triggered by chronically elevated levels of blood glucose. As many as half of all diabetic patients are expected to develop some form of DR in their lifetime. DR can progress from the non-proliferative (NPDR) stages to the proliferative (PDR) stage characterized by the growth of abnormal new blood vessels. Fewer than 1% of the 6.4 million NPDR patients in the U.S. receive treatment today, despite the availability of anti-VEGF therapies approved for the indication, largely due to the burden of frequent injections. Diabetic macular edema (DME) is also a leading cause of vision loss in the working-age population. DME, the result of an accumulation of fluid in the macula that can afflict patients with diabetes, can occur at any stage of DR. In patients with DME, blood vessels in the eyes leak and start to swell, which can cause vision loss or blindness. Anti-VEGF drugs are approved to treat DME, but these treatments typically require frequent intravitreal injections, placing a significant burden on patients and physicians alike. About Ocular Therapeutix, Inc. Ocular Therapeutix, Inc. is an integrated biopharmaceutical company committed to redefining the retina experience. AXPAXLI™ (also known as OTX-TKI), Ocular’s investigational product candidate for retinal disease, is an axitinib intravitreal hydrogel based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) and diabetic retinal disease, including non-proliferative diabetic retinopathy (NPDR). Ocular’s pipeline also leverages the ELUTYX technology in its commercial product DEXTENZA®, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients and ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged two years or older, and in its investigational product candidate OTX-TIC, which is a travoprost intracameral hydrogel that has completed a Phase 2 clinical trial for the treatment of open-angle glaucoma or ocular hypertension. Ocular is currently evaluating next steps for the OTX-TIC program. Follow the Company on its website, LinkedIn, or X. DEXTENZA® is a registered trademark of Ocular Therapeutix, Inc. The Ocular Therapeutix logo, AXPAXLI™, ELUTYX™, and Ocular Therapeutix™ are trademarks of Ocular Therapeutix, Inc. Forward-Looking Statements This press release contains forward-looking statements of the Company regarding its future expectations, plans, and prospects; statements regarding the development and regulatory status of the Company’s product candidate AXPAXLI (also known as OTX-TKI), including the Company’s intentions to submit a new drug application for AXPAXLI based on Week 52 data from the Company’s SOL-1 Phase 3 clinical trial of AXPAXLI for the treatment of wet AMD, subject to ongoing formal discussions with the FDA; statements regarding the timing, design, enrollment, randomization, conduct and retention of subjects in the Company’s ongoing and planned clinical trials for AXPAXLI, including the SOL-1 and SOL-R Phase 3 clinical trials and the SOL-X trial for the treatment of wet AMD, and the HELIOS-3 trial for non-proliferative diabetic retinopathy; statements regarding the commercial potential of AXPAXLI; statements regarding the timing of the availability of data from the SOL-R trial; statements regarding the future commercialization of DEXTENZA; statements regarding the Company’s cash runway and the sufficiency of the Company’s cash resources; statements regarding the potential utility or adoption, if approved, of any of the Company’s product candidates, including AXPAXLI; statements regarding the Company’s intentions to hold an investor day and provide regulatory and other updates in June 2026; and other statements containing the words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “designed”, “goal”, “may”, “might”, “plan”, “position”, “predict”, “project”, “target”, “potential”, “will”, “would”, “could”, “should”, “continue”, and similar expressions, all of which constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties regarding the initiation, design, timing, conduct and outcomes of the Company’s ongoing clinical trials, including the Company’s SOL-1 trial, SOL-R trial, HELIOS-3 trial, SOL-X trial and potential HELIOS-2 trial; the timing and costs involved in commercializing any product or product candidate that receives regulatory approval; the risk that the U.S. Food and Drug Administration, or FDA, will not agree with the Company’s interpretation of the written agreements under the Special Protocol Assessments for AXPAXLI, including for the SOL-1 trial and HELIOS-2 trial; uncertainty as to whether the FDA will accept a new drug application for AXPAXLI on the basis of a single pivotal clinical trial; uncertainty as to the minimum clinical data required to demonstrate the safety of a proposed product candidate such as AXPAXLI, even if the FDA recognizes that only one pivotal clinical trial may be required to demonstrate efficacy; the risk that even though the FDA has agreed with the overall design of the SOL-1 trial, the FDA may not find that the data generated by the trial and submitted by the Company are sufficient to demonstrate the safety and efficacy of AXPAXLI to the degree necessary to support marketing approval for wet AMD; the risk that the FDA might not agree to the Company’s design, protocol, and statistical analysis plan of any of its clinical trials for which the Company has not obtained a Special Protocol Assessment, including the SOL-R trial; the risk that the Company and the FDA may not agree on the registrational pathway for any of its product candidates, including AXPAXLI; uncertainty as to whether the Company will be able to timely satisfy the FDA’s other requirements for regulatory approval of AXPAXLI, including the FDA’s Chemistry, Manufacturing and Control’s requirements, even if the Company can satisfy the FDA’s clinical requirements to demonstrate safety and efficacy; uncertainty as to whether the Company’s NDA will qualify for, or whether the FDA will agree to review the NDA, if accepted for filing, under the 505(b)(2) pathway and whether the 505(b)(2) pathway will provide any time-savings as compared to the traditional 505(b)(1) pathway; uncertainty as to what restrictions, if any, may be imposed on the label for AXPAXLI, if approved, pending the receipt of additional clinical data or otherwise; uncertainty as to whether the data from earlier clinical trials will be predictive of the data of later clinical trials, particularly later clinical trials that have a different design or utilize a different formulation than the earlier trials, whether preliminary or interim data from a clinical trial will be predictive of final data from such trial, or whether data from a clinical trial assessing a product candidate for one indication will be predictive of results in other indications; uncertainty as to the Company’s ability to retain regulatory approval of any product or product candidate that receives regulatory approval; uncertainty as to whether data from the Company’s SOL-X trial will demonstrate additional clinically meaningful, long-term benefits; uncertainties regarding the potential commercial advantages and/or position of the Company’s product candidates; uncertainty regarding the implementation and impact of most-favored-nation and other reference pricing regimes on the commercial potential of AXPAXLI, especially in markets outside the United States; availability of data from clinical trials and expectations for regulatory submissions and approvals; the Company’s scientific approach and general development progress; uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials; the Company’s existing indebtedness and the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default; and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this press release. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Investors & Media Ocular Therapeutix, Inc. Bill Slattery Vice President, Investor Relations [email protected]

TranscriptFY2026 Q12026-05-05

FY2026 Q1 earnings call transcript

Earnings source - 61 paragraphs
Operator

Morning, and welcome to the Ocular Therapeutix first quarter 2026 earnings conference call. At this time, all participants are in a listen-only mode. After the prepared remarks, we will conduct a question-and-answer session. If you would like to ask a question, please press star 1 on your telephone. As a reminder, this conference call is being recorded and will be available for replay on the investor relations section of the Ocular Therapeutix website. I would now like to turn the call over to Ocular's Vice President of Investor Relations, Bill Slattery Jr. Please go ahead, Mr. Slattery.

Bill Slattery Jr.

Good morning, everyone, and thank you for joining us today. Earlier this morning, we issued a press release and filed our quarterly report on Form 10-Q, outlining our financial results and business updates for the first quarter of 2026. During today's call, Ocular's Executive Chairman, President, and CEO, Dr. Pravin Dugel, will summarize recent business highlights before we move to our question-and-answer session. Joining Dr. Dugel for the Q&A portion of the call will be Donald Notman, Chief Operating Officer, Sanjay Nayak, Chief Strategy Officer, and Steve Meyers, Chief Commercial Officer. We refer everyone to this morning's press release and our Form 10-Q for a comprehensive update of our first quarter 2026 financial and business results. During today's call, certain statements we will be making constitute forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Bill Slattery Jr.

Actual results may differ materially as a result of a variety of risk factors, including risks and uncertainties identified in the Risk Factors section of our annual report on Form 10-K and our other SEC filings. With that, I'd like to hand the call over to Dr. Pravin Dugel to review our recent updates. Pravin.

Pravin Dugel

Thank you, Bill, and thank you all for joining us this morning. 2026 is off to a tremendous start for Ocular Therapeutix, and I want to begin by stating this clearly. SOL-1 has fundamentally changed the conversation in wet AMD. In February, AXPAXLI became the first novel investigational therapy to demonstrate superiority to an approved anti-VEGF agent in a phase III wet AMD trial. That has never been done before. The magnitude, consistency, and statistical strength of the data with a P value of 0.0006 for our primary endpoint are giving the retina community great confidence in the robustness of the result and the probability of a potential approval as we prepare to submit our NDA based on SOL-1 week 52 data, subject to ongoing formal discussions with the U.S. FDA.

Pravin Dugel

Beyond the statistics, what truly excites us is the clinical significance of the data. AXPAXLI delivered unmatched durability and sustained disease control with substantially fewer rescues. In two-thirds of the patients, just a single AXPAXLI injection maintained vision for an entire year. That is not incremental progress. That is true differentiation. Most importantly, we're not slowing down. Just last week, we announced the initiation of enrollment in SOL-X, our long-term extension trial in wet AMD designed to explore AXPAXLI's impact on the long-term outcomes that matter most to patients and retina specialists. Since the top-line announcement, we have continued to analyze the SOL-1 results, and each successive data presentation only strengthens our conviction. Both at The Macula Society and most recently at the Vitreous Society annual meeting, we presented additional 52-week analyses that further reinforce AXPAXLI's unprecedented profile.

Pravin Dugel

For example, when we look at time to fluid volume increases, specifically thresholds of greater than 30 and 75 microns from week 8, subjects treated with AXPAXLI took about 5-6 months longer to reach those thresholds as compared to subjects in the aflibercept arm. This is exceptional disease control. Why does this matter? Fluid is the key marker of disease activity in wet AMD. Lower fluid accumulation reflects slower anatomic progression, and slower anatomic progression reflects sustained disease control. That has important implications for the long term, which we are further evaluating in SOL-X. Over time, inconsistent or pulsatile VEGF suppression, as we see in today's real-world clinical practice, may contribute to irreversible changes such as fibrosis and atrophy. What AXPAXLI may offer is something fundamentally different, continuous zero-order drug release and consistent disease control, which we believe could significantly alter the long-term trajectory of disease.

Pravin Dugel

What we have seen to date in SOL-1 with AXPAXLI is not just durability in terms of dosing intervals. It is also durability in terms of disease control. That distinction will continue to be important. Furthermore, when you consider the patients who were randomized in SOL-1, it becomes even clearer that what we have demonstrated with AXPAXLI is simply remarkable. It's worth remembering that SOL-1 enrolled what may be the best seeing wet AMD population ever studied in a Phase III trial. As you will recall, treatment-naive subjects needed to reach 20-20 vision or gain 10 letters over 8 weeks screening and loading phase to be randomized into the trial. Since we started recruitment, we've consistently said that this population was intentionally selected specifically because they are expected to lose vision.

Pravin Dugel

Yet, with a single injection of AXPAXLI, nearly 75% of patients maintained vision at 9 months and 66% maintained vision all the way through 12 months. That is simply profound. We also saw a meaningfully delayed time to first rescue compared to aflibercept. Incredibly, the rescue rate observed in the aflibercept arm at week 28 was not reached in the AXPAXLI arm until 6 months later at week 52. Just think about that. We're talking about a 6-month delay in clinically meaningful disease change. In wet AMD, that kind of separation has never been seen before. It speaks directly to the durability and sustained disease control that define AXPAXLI's profile. Most importantly, AXPAXLI was shown to be well-tolerated in SOL-1. We have made a conscious decision to be extremely transparent with regards to safety simply because it is so important in retinal vascular diseases.

Pravin Dugel

In our The Macula Society and Vit-Buckle Society presentations, we went so far as to provide subject-level details showing that AXPAXLI is performing as exactly as expected and is eluding drug and bioresorbing when it should. We did not observe a single treatment-related serious ocular or systemic adverse event such as endophthalmitis or vasculitis that would be caused for concern. When you combine our superiority, durability, sustained disease control, and a reassuring safety profile, you begin to see the profile of a product that retina specialists could adopt with confidence. If approved, we believe AXPAXLI has the potential to become a foundational therapy in wet AMD. Based on the strength of the results, we remain on track to submit our NDA relying on SOL-1 week 52 data, subject to ongoing formal discussions with the FDA.

Pravin Dugel

The FDA continues to publicly communicate plans to move to a single registrational trial as the new default option for approvals. The agency's commissioner recently noted that he expects this new framework to be phased in over the next few months or so, aligning with our goal of bringing AXPAXLI to patients as soon as possible. We intend to leverage the 505(b)(2) pathway, which may further allow for a shortened review timeline. Importantly, we are accelerating commercial readiness in parallel. We are building the infrastructure, engaging payers, refining our commercial strategy, and preparing for what we believe will be one of the most important launches in retina in many years. Turning to SOL-R, we completed randomization of 631 subjects in December 2025, exceeding our original 555 subject target. Because of this swift enrollment, we recently accelerated our guidance for SOL-R top-line data to the first quarter of 2027.

Pravin Dugel

This trial was specifically designed to complement SOL-1. Whereas SOL-1 demonstrated superiority, SOL-R evaluates non-inferiority in a de-risked population. Importantly, our 24-week screening and loading phase occurs prior to randomization, and this is designed to screen out those subjects with high fluid fluctuations, which have notoriously derailed prior non-inferiority trials. The design reflects real-world clinical practice and incorporates rescue criteria more closely aligned with how physicians treat patients. It is powered to provide additional data supporting rapid clinical adoption. Retention in SOLAR is strong, and site engagement remains tremendous. Based on the success of SOL-1, our confidence in SOLAR has never been higher. In addition to SOL-1 and SOLAR, we are thrilled to have recently announced the initiation of enrollment in SOL-X, our open label long-term extension study in wet AMD. Following the remarkable results from SOL-1, where AXPAXLI demonstrated unmatched durability and sustained disease control.

Pravin Dugel

SOL-X is designed to evaluate the long-term outcomes that matter most to patients and physicians. Subjects who have completed 2-year follow-up in SOL-1 or SOLAR will now have an opportunity to receive AXPAXLI for an additional 3 years in SOL-X, bringing the total follow-up to 5 years. That is critical because wet AMD is a chronic disease. In clinical practice, we see the consequences of inconsistent disease control over time, progressive damage that can ultimately limit long-term visual outcomes, including through fibrosis and atrophy. Because all subjects in SOL-X will ultimately transition to AXPAXLI, we will have a unique opportunity to observe the consequences of delaying AXPAXLI treatment. Patients initially treated with aflibercept in SOL-1 and SOLAR are exposed to what we would describe as pulsatile VEGF suppression, where disease control can fluctuate over time compared to the continuous suppression we have observed with AXPAXLI.

Pravin Dugel

If that difference translates into worse long-term outcomes for patients who begin on aflibercept and switch later, it would provide physicians with a clear rationale to initiate AXPAXLI earlier in the disease course rather than waiting. If successful, this has implications far beyond durability. It has the potential to improve long-term vision outcomes, reduce cumulative treatment burden, importantly, keep significantly more patients on therapy over time, which we believe could meaningfully expand the overall market. When we think about AXPAXLI, we're not just thinking about a more durable therapy. We're thinking about a therapy that has the potential to be transformative over the long term. SOL-X is a critical step in potentially demonstrating that. Beyond wet AMD, our HELIOS-3 trial in diabetic retinopathy remains ongoing. This is a superiority study designed to support a broad label across diabetic retinal disease.

Pravin Dugel

It allows enrollment of patients with non-central involved DME, reflecting the continuum of disease in clinical practice. On June 17th, in New York City, we will host an investor day and plan to provide several important updates across our portfolio. We will provide regulatory updates regarding our NDA submission plan in wet AMD, detailed updates on SOLAR and SOL-X, program updates on diabetic retinopathy, and a first look at our planned commercialization strategy for AXPAXLI. In addition to Ocular leadership, we will feature leading retinal KOLs who will share their perspective on the SOL-1 data, expectations for SOLAR, the evolving wet AMD treatment landscape, and how AXPAXLI could be adopted immediately if approved. We hope you all plan to join us either in person or virtually for what we expect will be an important day outlining the future of Ocular Therapeutix.

Pravin Dugel

As of March 31st, our financial position continues to remain strong. We ended the first quarter with approximately $667 million in cash, which we expect to provide us runway into 2028. That provides us the flexibility to advance the NDA submission, complete the second year of SOL-1, continue SOLAR, SOL-X, and our HELIOS program, and accelerate commercial readiness. Our cash runway does not include the full expenses we anticipate we will need to support the commercialization of AXPAXLI. We remain disciplined stewards of capital while investing strategically in what we believe is a transformational opportunity. Before we turn to Q&A, I'd like to close with a few important messages summarizing our incredible position coming out of the first quarter. AXPAXLI has now demonstrated through SOL-1 the first successful superiority outcome for a novel investigative agent in wet AMD against an approved anti-VEGF.

Pravin Dugel

Unmatched durability with sustained disease control through 1 year. A safety profile that supports broad clinical adoption. In addition, with the initiation of SOL-X, we now have a clear path to evaluating long-term outcomes with AXPAXLI and its potential to fundamentally alter the trajectory of disease. Together, we believe this combination has the potential to redefine the retina experience. Our organization is energized. The data are compelling. Execution remains exceptional. We're advancing with urgency toward our planned NDA submission and potential commercialization. Thank you all for your continued support. Operator, we can now take our first question.

Operator

Thank you. As a reminder at this time, if you would like to ask a question, it is the star and one on your touch-tone telephone. If at any point you find your question has been answered, you may remove yourself from the queue by pressing star two. We'll take our first question from Tazeen Ahmad with Bank of America. Please go ahead. Your line is open.

Tazeen Ahmad

Hi, guys. Good morning. Thanks for taking my question, and thanks for all of the clarification on timelines. Pravin, I just wanted to get a sense of how the discussions with FDA are going. A couple of things. You've been confident on your view that you can apply with just SOL-1 to get approval. Today you provided the good news that SOL-R has enrolled at a pace that you're gonna be able to have data in the first quarter. Maybe can you walk us through the scenarios of what the timeline differences would be if it's decided that you can apply with SOL-1 versus a decision that it might be better to wait for SOL-R? Thank you.

Pravin Dugel

Tazeen, good morning, and thank you so much for the question. Very appropriate question. Look, what we've said today and what we've said in the past, is that we have ongoing formal discussions with the FDA. We couldn't be happier, and I want to stress, we couldn't be happier with the collaboration that we have with the FDA. We feel we're more aligned with the FDA's goals than ever. We check all the boxes. What's been demonstrated to us over and over again in our discussions and in the writings of the FDA is that there are 2 things that are really important with this single trial submission that I think everybody ought to note. First of all, it's a default position for the FDA. Second, the FDA views this as an elevation of the standards for a clinical trial.

Pravin Dugel

This is not a lowering of the bar. This is a raising of the bar. SOL-1 checks all the boxes. It has a SPA. It checks all the boxes in terms of the superiority standard that was reached in terms of safety. We're more aligned than ever. In terms of your question regarding SOL-R, look, we haven't disclosed the timelines as yet. We will when appropriate. I remind you that we have a lot of flexibility here in terms of SOL-R. Nothing is changing with SOL-R. We're continuing with SOL-R with the same kind of efficiency that we've always demonstrated. We're very, very happy with the engagement of the PIs and the enrollment of SOL-R, and nothing has changed. I want to reiterate, we have ongoing formal discussions with the FDA. We couldn't be happier.

Pravin Dugel

When the time is appropriate, we certainly will update you. Thank you, Tazeen, for that question.

Operator

Thank you. We'll take our next question from Biren Amin from Piper Sandler. Please go ahead.

Biren Amin

Yeah. Hi, guys. Thanks for taking my questions. I just wanna welcome back, Donald. Great to have you back, Donald. You know, regarding the ongoing formal discussions with FDA, Pravin, can you maybe just talk about if you've had the pre-NDA meeting with the FDA? That's the first question. The second question, you know, for SOL-1 in the past, you had provided a snapshot on patient discontinuations and patient retention in the study. I was wondering if you could discuss these dynamics for the SOL-R study. Thank you.

Pravin Dugel

Biren, good morning, and thank you, and thank you for the personal note regarding Donald. We too are absolutely thrilled to have Donald back, and he's a essential part of our team. We couldn't be happier that he's back with us. In regards to the FDA meetings, again, I wanna emphasize what I said earlier on, Biren, which is that we are not in the habit of disclosing the details of our FDA meetings, as is true for most sponsors. Suffice it to say that we have ongoing formal meetings that we're very pleased with. The collaboration with the FDA today and has been demonstrated historically could not be better. You recall all the modifications that we've had, and have preserved our SPA with this study.

Pravin Dugel

You also recall the modifications that we've had with the SOL-R study. All of those have been done in collaboration with the FDA, and we couldn't be happier with their support and their collaboration. As I said earlier, when appropriate, we certainly will update you regarding the timelines. In regards to SOL-R, again, a very appropriate question. As you recall, we had a phenomenal retention rate and execution with SOL-1. That has not changed in SOL-R. We're very pleased with the execution. We're very pleased with the stats that we have in regards to patient retention, and you'll hear the details of that in our upcoming Investor day. I'm sorry.

Pravin Dugel

I hope that all of you will be present for that in New York City on June seventeenth. Thank you for that question, Biren. Back to the operator.

Operator

Thank you. We'll take our next question from Tara Bancroft with TD Cowen. Please go ahead.

Tara Bancroft

Hi, good morning. I'm going to stick on this theme, if I may. You know, I understand you can't give exact timing and all of that, of course, to preserve the integrity of the discussions. I was hoping maybe you could go over with us what has to be done ahead of a filing, just to get a better sense of the process as you understand it. Kind of separately and related, potentially timing to when we could get an update on data from SOL-X and whether this is going to be part of that review that's expected for the NDA. Thanks so much.

Pravin Dugel

Tara, good morning, and thank you for the question. Look, in regards to the FDA again, you know, I'll repeat that we check all the boxes. We're completely aligned, and I think everything that you've seen from the FDA is in line with their intention of getting drugs to patients faster and making sure that the trials or the single trial approval process is validated. You've seen all the editorials or the editorial in New England Journal of Medicine. You've seen the criteria that was laid out by the commissioner. We check all the boxes, and in our discussions with the FDA, we're more confident than ever that we check all the boxes.

Pravin Dugel

In addition to that, as I said earlier, SOLAR also provides us a tremendous amount of flexibility. It's important to note again that nothing has changed with SOLAR. We're moving with SOLAR as efficiently, as quickly, with a great deal of integrity, and nothing is gonna change with that. We're moving with that and preserving the flexibility of whatever the FDA should desire. In regards to your question regarding SOL-X and the updates, we will provide more updates in our meeting in June in New York City. Important to remember that SOL-X will provide some very important information in regards to the long-term effectiveness of AXPAXLI. As has been mentioned, SOL-X will provide a lot of data.

Pravin Dugel

Probably one of the most important data points that SOL-X will provide are the crossover patients. We've said earlier that there's a great deal of evidence in our field that what causes long-term decrease in vision is atrophy and fibrosis that is, that is caused by the pulsatile nature of our treatment. I've also mentioned several times that that's akin to having multiple concussions because after all, this is neural tissue. We believe that with continuous suppression that AXPAXLI will provide, and by eliminating these pulsations, we will have a much better long-term outcome by having less fibrosis and less atrophy. Remember, in SOL-X, patients will cross over to AXPAXLI after receiving two years of pulsatile treatment.

Pravin Dugel

We don't think those patients will ever catch up, and we believe that we'll be able to demonstrate not only the remarkable sustainability and absolutely incredible disease control that we've seen with SOL-1, but we believe we'll also be able to provide substantial evidence that it will provide a better long-term outcome by having continuous suppression. Again, more details on that, Tara, in our meeting in June in New York City, which I hope you will attend. Thank you again for the question, and back to you, operator.

Operator

Certainly. We'll go next to Sean McCutcheon with Raymond James. Please go ahead. Sean, your line is open.

Yang Long

Hi, good morning, team. This is Yang Hong for Sean. Maybe can you speak to the optionality of adding SOLAR to the safety database for the NDA submission? Also the risk of unmasking SOLAR if left on the table as it relates to maintaining the integrity of SOLAR for global approvals? Thank you.

Pravin Dugel

Good morning, thank you again for the question. A very appropriate question. I don't want to speak again, as I said earlier on, to the details of our conversations with the FDA. Suffice it to say that they're very collaborative, supportive, ongoing, and formal. What I will say is we have no intention of doing anything different to SOLAR whatsoever. The flexibility that that provides us in terms of the safety database is enormous, let alone the fact that we also have the HELIOS study. It's important to remember that in SOL-1, everybody at week 52 has been redosed. In SOL-1 alone, there's a great deal of redosing experience. Obviously, there's a great deal of redosing experience in SOLAR as well. Again, that affords us a great deal of flexibility.

Pravin Dugel

On top of that, it's important to note that what we're filing is a 505(b)(2) because both of these entities are previously FDA approved. This drug has a lot of familiarity with the FDA. On top of that, we have a SPA, which we believe will also add to a very efficient filing. Thank you for your question. Again, back to the operator.

Operator

Thank you. We'll go next to Lisa Walter with RBC Capital Markets. Please go ahead.

Lisa Walter

Good morning. Thanks for taking our question, congrats on the progress this quarter. A couple for me. On SOLAR, just wondering if you can walk us through the secondary endpoints that you expect to share, maybe could you tell us how you are measuring reduction in injection burden as well? Any color here would be helpful. Thanks.

Pravin Dugel

Lisa, good morning and thank you again. In SOLAR, we certainly will plan to share the details with you of what we will study in our meeting in June, wait for the details for that. In terms of injection burden, obviously we're gonna be measuring the rescue rates, again, we'll share the details with that in our meeting in June. It's important to state that I think a lot of the questions that you've asked that you're concerned about, which is very appropriate, have already really been answered in SOL-1. In SOL-1, we certainly see the disease control of AXPAXLI. It's important to remember the patient population difference in SOLAR and SOL-1.

Pravin Dugel

In SOL-1, patients were specifically and intentionally selected to lose vision, and that's important to understand, and I think that's something that has often been neglected. Despite that patient population, we saw an almost 75% rescue-free rate at week 36, and that's quite remarkable. Perhaps more remarkable, and perhaps even more clinically relevant, is that with a single injection, despite that patient population, 56% maintained a stable CST within 30 microns. Again, I emphasize 30 microns at that time point, and that's unheard of. Remember, using the SOLAR criteria, almost 80% of patients were rescue-free in SOL-1 at 6 months. We feel that those 20% would perhaps be excluded in SOLAR, given our very long ramp and given the fact that we have 2 opportunities to observe patients for fluctuations.

Pravin Dugel

We expect an even higher rescue-free rate in SOLAR. We believe that AXPAXLI is very well-positioned to succeed in the non-inferiority SOLAR trial. Lisa, thank you again for your question. Again, a lot of those details will be addressed in the meeting in June in New York City, which I hope you will attend. Thank you again. Back to you, the operator.

Operator

Thank you. We'll go next to John Wallenben with Citizens. Please go ahead.

Jon Wolleben

Hey, thanks for taking the question. Just wondering, Pravin, if you could talk a little bit about the feedback you've received and how retina specialists plan on potentially integrating AXPAXLI in the practice based on SOL-1, and how that might change with the SOLAR readouts.

Pravin Dugel

Good morning, and thank you for the question. Great question. You know, that's the discussion going on right now. My colleagues expect to have this medicine in their hands, and the discussion that's going on right now is how will they be using it, and how will they be introducing it to their patients? Which is a great discussion to have. I think ultimately, what I think at least, and this is just my hypothesis, is that this is the ideal drug to be every 6 months, fixed dosing drug.

Pravin Dugel

As I've said, to have a drug that lasts, that is a fixed dosing confident, every 6-month drug, one also has to be confident that that drug will last beyond 6 months, maybe 9 to 10 months, in case the patient gets sick, the doctor is on vacation, that kind of thing. This is the ideal drug for that. How doctors will get to that fixed dosing is something that I think will be explored by the community. Some feel that they'll directly go to fixed dosing. I've had those discussions with my colleagues. Others feel that what they will initially do is to have an extended treat and extend that will continue to give them more and more confidence to go to that every 6-month fixed dosing.

Pravin Dugel

However they go there, I believe that's where this drug will end up. I think that will transform the way we treat patients with wet AMD. In fact, I think that will align us with the rest of medicine. I've always said that, treat and extend, which is what we do now, is sort of opaque. If you ask your 10 KOLs what treat and extend means, you'll get 10 different answers. There's really no study on treat and extend in a phase III program. Treat and extend is not on any label, it certainly is not aligned with anything we do in medicine.

Pravin Dugel

You don't go to your cancer doctor and say, "Look, I'll wait until your bladder cancer comes back before I decide how often to see you." You certainly don't go to your cardiologist, who says, "Look, I'll wait for your first heart attack before I figure out how often to treat you." This type of fixed dosing I think is aligned with medicine. I think there's good scientific data to support it, and I think that this drug is ideal for every 6-month dosing. The other important thing is that the adaptability, I think, will be very, very quick, and it will be seamless. Nothing changes for the doctor. The workflow doesn't change. The experience doesn't change. It's a self-sealing 25 gauge needle. There's not a single new piece of equipment to buy. There's no added overhead.

Pravin Dugel

I think the adaptability of this will be absolutely seamless. I know that in talking to my colleagues, they are very enthusiastic to use this drug as soon as it's marketed. Thank you for your question, and back to the operator.

Operator

Thank you. We'll go next to Yi Chen with H.C. Wainwright & Co. Please go ahead.

Yi Chen

Thank you for taking my questions. Pravin, could you comment on whether there are any patients who have dropped out of the SOL-1 trial and whether any patients from SOL-1 who are eligible to enroll into the SOL-X trial have chosen to do so? If not, what are their reasons for not enrolling into the SOL-X trial? Thank you.

Pravin Dugel

Thank you again for your question. We haven't given the actual numbers, but suffice it to say that the retention rate is absolutely remarkable, and I'll go so far as to say that the retention rate is probably better than any other retina phase III study that we know of. This speaks to the enthusiasm not only of the patients but also the doctors. Historically, this is borne out, right? I go back to LUCENTIS and EYLEA, for instance. LUCENTIS had a 7-year head start. EYLEA came in 7 years later and extended the durability by maybe 1 week or 2 and absolutely dominated the market. You see the same kind of thing with VABYSMO now. This is a real need in our community. Doctors know this. Patients know this.

Pravin Dugel

Seeing the data that they've seen with SOL-1 makes it very, very easy for patients and for doctors to stick with this program. There's been an overwhelming amount of enthusiasm. We haven't given you the actual numbers, but again, the retention rate of this program, I'll go so far as to say is higher than any other phase III program that I know, and the enthusiasm is through the roof at this point. Thank you for your question. Back to the operator.

Yi Chen

Thank you.

Operator

Thank you. As a reminder, if you would like to ask a question, that is the star and one on your telephone keypad. We'll go next to Lachlan Hanbury-Brown from William Blair. Please go ahead. Your line is open.

Truman Dunkley

Hi. Truman Dunkley on for Lachlan. I just wanted to ask, for the HELIOS-3 study, can you remind us if there's a certain proportion of patients that you will need to enroll with non-CI DME to ensure that you have enough data to get DME in the label?

Pravin Dugel

No, thank you for your question. Good morning. There is really no such requirement that we have guided you to. You know, what I will say is we are very confident that we will not need to do another diabetic retinopathy study to cover all of diabetic retinal disease. I say that because remember, what we're doing is enrolling patients with a moderate to severe non-proliferative diabetic retinopathy with non-central involving diabetic macular edema with an ordinal endpoint, which captures every facet of change with non-proliferative diabetic retinopathy. The FDA historically has given approval based on the disease as opposed to the clinical trial. We absolutely believe that we will have a label that will cover all of diabetic macular edema.

Pravin Dugel

You've seen evidence for this over and over again. If you go way back to ANCHOR and MARINA, for instance, there was a restriction in visual acuity in enrollment, and you see that for LUCENTIS, there is no restriction whatsoever. You look at PANORAMA, there is no restriction for a stage of non-proliferative diabetic retinopathy in the label. Most recently, my last company, IVERIC bio, recall that we didn't treat a single patient with center involving geographic atrophy, yet if you look at the label for IZERVAY, it allows for all of geographic atrophy, fovea involving and non-foveal involving. In the same way, we believe that with the label eventually, for AXPAXLI will cover all of diabetic macular edema, central involving and non-central involving.

Pravin Dugel

Also recall that everybody with diabetic macular edema, everybody also has non-proliferative diabetic retinopathy. All of diabetes will be covered, we believe, by the label. I will add that obviously we haven't had labeling discussions with the FDA. It is far too early for that. We firmly believe that this will be the only trial that will be necessary in the HELIOS programs for a broad label encompassing all of diabetic retinopathy. Thank you again for the question. Back to you, operator.

Operator

Thank you. At this time, there are no further questions in queue. This concludes our question and answer session. I will now turn the call back to Dr. Pravin Dugel for closing remarks.

Pravin Dugel

Thank you. Once again, thank you all for joining us today, and thank you for your continued support. We hope you will join us on June 17th in New York City for our upcoming Investor Day. In the meantime, if you have any questions, please reach out to Bill Slattery, our Vice President of Investor Relations. Have a great day, everyone, and thank you.

Operator

Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.

Investor releaseQuarter not tagged2026-05-04

Ocular Therapeutix (OCUL) To Report Earnings Tomorrow: Here Is What To Expect

StockStory

Ophthalmology biopharmaceutical company Ocular Therapeutix (NASDAQ:OCUL) will be announcing earnings results this Tuesday before the bell. Here’s what to look for. Ocular Therapeutix missed analysts’ revenue expectations last quarter, reporting revenues of $13.25 million, down 22.4% year on year. It was a slower quarter for the company, with a significant miss of analysts’ revenue estimates. Is Ocular Therapeutix a buy or sell going into earnings? Read our full analysis here, it’s free for active Edge members. This quarter, the market is expecting Ocular Therapeutix’s revenue to grow 20.8% year on year, a reversal from the 27.6% decrease it recorded in the same quarter last year. The majority of analysts covering the company have reconfirmed their estimates over the last 30 days, suggesting they anticipate the business to stay the course heading into earnings. Ocular Therapeutix has missed Wall Street’s revenue estimates multiple times over the last two years. Looking at Ocular Therapeutix’s peers in the pharmaceuticals segment, some have already reported their Q1 results, giving us a hint as to what we can expect. Eli Lilly delivered year-on-year revenue growth of 55.5%, beating analysts’ expectations by 13.7%, and Merck reported revenues up 4.9%, topping estimates by 3%. Eli Lilly traded up 13.2% following the results while Merck was also up 1%. Read our full analysis of Eli Lilly’s results here and Merck’s results here. There has been positive sentiment among investors in the pharmaceuticals segment, with share prices up 6% on average over the last month. Ocular Therapeutix is up 16.5% during the same time and is heading into earnings with an average analyst price target of $26 (compared to the current share price of $9.40). WHILE YOU’RE HERE: The Next Palantir? One satellite company captures images of every point on Earth. Every single day. The Pentagon wants it. Hedge funds are using it to beat earnings. You’ve probably never heard of it. This is what the early days of Palantir looked like before it became a $437 billion giant. Same playbook. Different technology. If you missed Palantir, you need to see this. Claim The Stock Ticker for Free HERE.

Investor releaseQuarter not tagged2026-04-28

Ocular Therapeutix™ to Report First Quarter 2026 Financial Results on May 5, 2026

GlobeNewswire
BEDFORD, Mass., April 28, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced that it plans to host a conference call and webcast on Tuesday, May 5, 2026 at 8:00 AM ET to discuss recent business progress and financial results for the first quarter ended March 31, 2026. Conference Call and Webcast Information: Date: Tuesday, May 5, 2026 at 8:00 AM ET Participant Dial-In (U.S.): 1-800-343-4136 Participant Dial-In (International): 1-203-518-9843 Conference ID: OCULAR (required for entry) Webcast Access: Please click here The live and archived webcast can also be accessed by visiting the Ocular Therapeutix website on the Events and Presentations section of the Investor Relations page. A replay of the webcasts will be archived for at least 30 days following the presentation. About Ocular Therapeutix, Inc. Ocular Therapeutix, Inc. is an integrated biopharmaceutical company committed to redefining the retina experience. AXPAXLI™ (also known as OTX-TKI), Ocular’s investigational product candidate for retinal disease, is an axitinib intravitreal hydrogel based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD), and diabetic retinal disease, including non-proliferative diabetic retinopathy (NPDR). Ocular’s pipeline also leverages the ELUTYX technology in its commercial product DEXTENZA®, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients and ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged two years or older, and in its investigational product candidate OTX-TIC, which is a travoprost intracameral hydrogel that has completed a Phase 2 clinical trial for the treatment of open-angle glaucoma or ocular hypertension. Ocular is currently evaluating next steps for the OTX-TIC program. Follow the Company on its website, LinkedIn, or X. DEXTENZA® is a registered trademark of Ocular Therapeutix, Inc. The Ocular Therapeutix logo, AXPAXLI™, ELUTYX™, and Ocular Therapeutix™ are trademarks of Ocular Therapeutix, Inc. Investors & Media Ocular Therapeutix, Inc. Bill Slattery Vice President, Investor…Read full document

BEDFORD, Mass., April 28, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced that it plans to host a conference call and webcast on Tuesday, May 5, 2026 at 8:00 AM ET to discuss recent business progress and financial results for the first quarter ended March 31, 2026. Conference Call and Webcast Information: Date: Tuesday, May 5, 2026 at 8:00 AM ET Participant Dial-In (U.S.): 1-800-343-4136 Participant Dial-In (International): 1-203-518-9843 Conference ID: OCULAR (required for entry) Webcast Access: Please click here The live and archived webcast can also be accessed by visiting the Ocular Therapeutix website on the Events and Presentations section of the Investor Relations page. A replay of the webcasts will be archived for at least 30 days following the presentation. About Ocular Therapeutix, Inc. Ocular Therapeutix, Inc. is an integrated biopharmaceutical company committed to redefining the retina experience. AXPAXLI™ (also known as OTX-TKI), Ocular’s investigational product candidate for retinal disease, is an axitinib intravitreal hydrogel based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD), and diabetic retinal disease, including non-proliferative diabetic retinopathy (NPDR). Ocular’s pipeline also leverages the ELUTYX technology in its commercial product DEXTENZA®, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients and ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged two years or older, and in its investigational product candidate OTX-TIC, which is a travoprost intracameral hydrogel that has completed a Phase 2 clinical trial for the treatment of open-angle glaucoma or ocular hypertension. Ocular is currently evaluating next steps for the OTX-TIC program. Follow the Company on its website, LinkedIn, or X. DEXTENZA® is a registered trademark of Ocular Therapeutix, Inc. The Ocular Therapeutix logo, AXPAXLI™, ELUTYX™, and Ocular Therapeutix™ are trademarks of Ocular Therapeutix, Inc. Investors & Media Ocular Therapeutix, Inc. Bill Slattery Vice President, Investor Relations [email protected]

As of 2026-08-29 • Updated weeklySource: Earnings sourceIngestion runbook