SGP
SpyGlassCDocument history
Earnings documents stored for SGP.
Investor releaseQuarter not tagged2026-08-27SpyGlass Pharma Celebrates Grand Opening of New Irvine Headquarters, Positioning Itself for First Product Launch and Custom R&D Space
PR Newswire
SpyGlass Pharma Celebrates Grand Opening of New Irvine Headquarters, Positioning Itself for First Product Launch and Custom R&D Space
Future portfolio expansion will advance a new era of ophthalmic care while driving continued growth of Irvine's MedTech and life sciences sector. IRVINE, Calif., Aug. 27, 2026 /PRNewswire/ -- SpyGlass Pharma, a biopharmaceutical clinical-stage company dedicated to transforming treatment for patients living with chronic eye conditions, today celebrated the grand opening of its new Irvine headquarters, marking a pivotal point in the company's growth. The opening of its 33,000-square-foot headquarters August 27 is a homecoming for SpyGlass Pharma, which established its first laboratory space in Irvine in 2021 before expanding to a larger facility in Aliso Viejo. After advancing its lead product candidate from the R&D phase to launch two robust Phase 3 clinical trials, the company outgrew its former facility following a successful IPO in February 2026, along with a strengthened leadership team and increased headcount. SpyGlass Pharma looked to expand its footprint as it plans to scale up for commercialization of its innovative sustained drug delivery system and advance its ophthalmology pipeline. "This is a special moment for SpyGlass," said Patrick Mooney, CEO of SpyGlass Pharma. "Our roots have always been in Orange County, and now we're thrilled to move our headquarters to Irvine for this significant growth phase of the company. Irvine has been a hub for innovation, and it only makes sense that SpyGlass is centrally located as we gear up for our first product launch and continue to develop additional innovative sustained drug delivery products for patients with chronic eye conditions." Since completing its initial public offering in February 2026, which raised $172.5 million in gross proceeds, SpyGlass Pharma has grown its workforce by 33% and now employs more than 85 people. "SpyGlass Pharma's decision to move to Irvine underscores our City's standing as a premier destination for growing businesses," said Mayor Larry Agran. "We are proud to welcome them back to our vibrant economic community." The new headquarters also provides expanded product development space as SpyGlass prepares for its next phase of growth. "Significantly expanding our operation in Irvine gives SpyGlass access to world-class talent in the competitive biotech environment," said James Dennewill, COO of SpyGlass Pharma. "The local talent, fed by a top-ranked public research university, com…Read full documentShow less
Future portfolio expansion will advance a new era of ophthalmic care while driving continued growth of Irvine's MedTech and life sciences sector. IRVINE, Calif., Aug. 27, 2026 /PRNewswire/ -- SpyGlass Pharma, a biopharmaceutical clinical-stage company dedicated to transforming treatment for patients living with chronic eye conditions, today celebrated the grand opening of its new Irvine headquarters, marking a pivotal point in the company's growth. The opening of its 33,000-square-foot headquarters August 27 is a homecoming for SpyGlass Pharma, which established its first laboratory space in Irvine in 2021 before expanding to a larger facility in Aliso Viejo. After advancing its lead product candidate from the R&D phase to launch two robust Phase 3 clinical trials, the company outgrew its former facility following a successful IPO in February 2026, along with a strengthened leadership team and increased headcount. SpyGlass Pharma looked to expand its footprint as it plans to scale up for commercialization of its innovative sustained drug delivery system and advance its ophthalmology pipeline. "This is a special moment for SpyGlass," said Patrick Mooney, CEO of SpyGlass Pharma. "Our roots have always been in Orange County, and now we're thrilled to move our headquarters to Irvine for this significant growth phase of the company. Irvine has been a hub for innovation, and it only makes sense that SpyGlass is centrally located as we gear up for our first product launch and continue to develop additional innovative sustained drug delivery products for patients with chronic eye conditions." Since completing its initial public offering in February 2026, which raised $172.5 million in gross proceeds, SpyGlass Pharma has grown its workforce by 33% and now employs more than 85 people. "SpyGlass Pharma's decision to move to Irvine underscores our City's standing as a premier destination for growing businesses," said Mayor Larry Agran. "We are proud to welcome them back to our vibrant economic community." The new headquarters also provides expanded product development space as SpyGlass prepares for its next phase of growth. "Significantly expanding our operation in Irvine gives SpyGlass access to world-class talent in the competitive biotech environment," said James Dennewill, COO of SpyGlass Pharma. "The local talent, fed by a top-ranked public research university, combined with the expanded innovation space, will fuel SpyGlass innovation for years to come. For a company focused on enduring vision, we're excited to be partnering with a City that has built an enduring ecosystem for innovative medical technologies for over 50 years." About the City of IrvineSince its incorporation in 1971, Irvine has become a nationally recognized city, with a population of 317,744 that spans 66 square miles and is recognized as one of America's safest and most successful master-planned urban communities. Top-rated educational institutions, an enterprising business atmosphere, sound environmental stewardship, and respect for diversity all contribute to Irvine's enviable quality of life. This family-friendly city features more than 16,000 acres of parks, sports fields and dedicated open space and is the home of the Great Park. For more information, please visit cityofirvine.gov. About SpyGlass PharmaSpyGlass Pharma is a late-stage biopharmaceutical company dedicated to transforming the treatment paradigm for patients living with chronic eye conditions through long-acting, sustained drug delivery of approved medicines. The Company's mission is to significantly improve the lives of patients with chronic eye conditions by developing durable drug delivery solutions that can empower patients and surgeons with confidence in long-term disease control and vision preservation. The SpyGlass Pharma platform, a novel, non-bioerodible drug delivery technology, is designed to be used with various well-established, approved medicines, including bimatoprost and other small molecules, providing flexibility to potentially treat a range of conditions in the front and back of the eye. The Company was founded in 2019 by Malik Y. Kahook, M.D., and Glenn Sussman to solve the lack of ophthalmic innovations that capitalize on durable treatment options. The SpyGlass Pharma platform was originally developed in the Sue Anschutz-Rodgers Eye Center at the University of Colorado Anschutz School of Medicine. View original content to download multimedia:https://www.prnewswire.com/news-releases/spyglass-pharma-celebrates-grand-opening-of-new-irvine-headquarters-positioning-itself-for-first-product-launch-and-custom-rd-space-302862270.html
Investor releaseQuarter not tagged2026-08-06SpyGlass Pharma Reports Second Quarter 2026 Financial Results and Provides Corporate Updates
GlobeNewswire
SpyGlass Pharma Reports Second Quarter 2026 Financial Results and Provides Corporate Updates
Enrollment remains on track in the registrational Phase 3 trials of the Bimatoprost Drug Pad-IOL System (BIM-IOL System), with completion of enrollment expected in 2027. Bimatoprost-Drug Ring System (BIM-DRS) first-in-human trial is on track to start in the second half of 2026. Cash, cash equivalents and short-term investments of $234.2 million on June 30, 2026, are expected to fund planned operations through 2028. IRVINE, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- SpyGlass Pharma, Inc. (Nasdaq: SGP) (“SpyGlass Pharma” or “Company”), a late-stage biopharmaceutical company, today reported recent business highlights and financial results for the second quarter ended June 30, 2026. “We are pleased to report that enrollment in our parallel Phase 3 registrational trials of the BIM-IOL System, which if approved by the US Food and Drug Administration, has the potential to serve the approximately one million annual cataract procedures in glaucoma and ocular hypertension patients, remains on track for completion in 2027. In parallel, SpyGlass remains diligently focused on initiating our first-in-human study of our next-generation BIM-DRS with the potential to provide lasting intraocular pressure reduction to every pseudophakic glaucoma patient, which would grow the addressable patient population substantially, in the second half of this year,” stated Patrick Mooney, chief executive officer of SpyGlass Pharma. “Collectively, our BIM-IOL System and BIM-DRS hold the potential to provide long-term, drop-free glaucoma treatment and sustained visual protection.” Corporate Highlights Dedicated Reimbursement Pathway for BIM-IOL System. In May 2026, the American Medical Association’s CPT® (Current Procedural Terminology) Editorial Panel approved a new add-on Category III CPT code (+1090T released to AMA website on July 1, 2026) in combination with established Category I CPT codes, such as 66984 and 66991. The Company believes the dedicated reimbursement pathway for surgeons could accelerate commercial adoption of the BIM-IOL System. Strengthened Commercial Leadership. In June 2026, SpyGlass Pharma appointed Mike Pinder as Vice President, Marketing. Mr. Pinder will leverage his deep experience of successfully building and launching buy-and-bill ophthalmology treatments as SpyGlass Pharma approaches a potential commercialization of the BIM-IOL System. Glaucoma and Cataract Surge…Read full documentShow less
Enrollment remains on track in the registrational Phase 3 trials of the Bimatoprost Drug Pad-IOL System (BIM-IOL System), with completion of enrollment expected in 2027. Bimatoprost-Drug Ring System (BIM-DRS) first-in-human trial is on track to start in the second half of 2026. Cash, cash equivalents and short-term investments of $234.2 million on June 30, 2026, are expected to fund planned operations through 2028. IRVINE, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- SpyGlass Pharma, Inc. (Nasdaq: SGP) (“SpyGlass Pharma” or “Company”), a late-stage biopharmaceutical company, today reported recent business highlights and financial results for the second quarter ended June 30, 2026. “We are pleased to report that enrollment in our parallel Phase 3 registrational trials of the BIM-IOL System, which if approved by the US Food and Drug Administration, has the potential to serve the approximately one million annual cataract procedures in glaucoma and ocular hypertension patients, remains on track for completion in 2027. In parallel, SpyGlass remains diligently focused on initiating our first-in-human study of our next-generation BIM-DRS with the potential to provide lasting intraocular pressure reduction to every pseudophakic glaucoma patient, which would grow the addressable patient population substantially, in the second half of this year,” stated Patrick Mooney, chief executive officer of SpyGlass Pharma. “Collectively, our BIM-IOL System and BIM-DRS hold the potential to provide long-term, drop-free glaucoma treatment and sustained visual protection.” Corporate Highlights Dedicated Reimbursement Pathway for BIM-IOL System. In May 2026, the American Medical Association’s CPT® (Current Procedural Terminology) Editorial Panel approved a new add-on Category III CPT code (+1090T released to AMA website on July 1, 2026) in combination with established Category I CPT codes, such as 66984 and 66991. The Company believes the dedicated reimbursement pathway for surgeons could accelerate commercial adoption of the BIM-IOL System. Strengthened Commercial Leadership. In June 2026, SpyGlass Pharma appointed Mike Pinder as Vice President, Marketing. Mr. Pinder will leverage his deep experience of successfully building and launching buy-and-bill ophthalmology treatments as SpyGlass Pharma approaches a potential commercialization of the BIM-IOL System. Glaucoma and Cataract Surgeon Engagement. Throughout the second quarter, SpyGlass Pharma has accelerated its engagement with the cataract and glaucoma surgeon community through industry and medical meetings, including the American-European Congress of Ophthalmic Surgery, a global, premier medical meeting highlighting the top innovations in surgical ophthalmology, and the Octane Orange County Ophthalmology Tech Forum. SpyGlass Pharma was featured prominently in both meetings, building broader awareness and engagement around the Company and its lead product candidate, the BIM-IOL System. Second Quarter 2026 Financial Results Cash, Cash Equivalents and Short-Term Investments totaled $234.2 million as of June 30, 2026. Research and Development Expenses were $10.9 million for the second quarter of 2026, compared to $7.3 million for the second quarter of 2025. The increase was primarily due to the hiring of clinical personnel. General and Administrative Expenses were $11.0 million for the second quarter of 2026, compared to $2.0 million for the second quarter of 2025. The increase was primarily due to higher professional service fees and personnel costs. Net Loss was $19.9 million, or ($0.59) per basic and diluted share, for the second quarter of 2026, compared to $8.7 million, or ($3.81) per basic and diluted share, for the same period of 2025. Upcoming Milestones BIM-DRS: Initiation of the FIH trial expected in the second half of 2026. BIM-IOL System: Four-year efficacy and safety follow-up expected in fourth quarter of 2026. About the Bimatoprost Drug Pad-IOL System SpyGlass Pharma’s lead product candidate, the Bimatoprost Drug Pad-IOL System (BIM-IOL System), comprising novel, proprietary non-bioerodible drug pads attached to its intraocular lens, was designed to be implanted during routine cataract surgery to reduce elevated intraocular pressure (IOP) in patients who have either open-angle glaucoma (OAG) or ocular hypertension (OHT). The BIM-IOL System is designed to consistently deliver three years of bimatoprost, a prostaglandin analog approved for topical use by the U.S. Food and Drug Administration (FDA) in 2001, for the reduction of elevated IOP in patients with OAG or OHT. The Company initiated two registrational Phase 3 clinical trials of the BIM-IOL System and continues long-term follow-up of patients in the Phase 1/2 study investigating the safety and efficacy of the BIM-IOL System. SpyGlass Pharma plans to work with the FDA to advance the program through completion of Phase 3 clinical trials, New Drug Application submission, and ultimately to potential FDA approval. About SpyGlass Pharma SpyGlass Pharma is a late-stage biopharmaceutical company dedicated to transforming the treatment paradigm for patients living with chronic eye conditions through long-acting, sustained drug delivery of approved medicines. The Company’s mission is to significantly improve the lives of patients with chronic eye conditions by developing durable drug delivery solutions that can empower patients and surgeons with confidence in long-term disease control and vision preservation. The SpyGlass Pharma platform, a novel, non-bioerodible drug delivery technology, is designed to be used with various well-established, approved medicines, including bimatoprost and other small molecules, providing flexibility to potentially treat a range of conditions in the front and back of the eye. The Company was founded in 2019 by Malik Y. Kahook, M.D. and Glenn Sussman to solve the lack of ophthalmic innovations that capitalize on durable treatment options. The SpyGlass Pharma platform was originally developed in the Sue Anschutz-Rodgers Eye Center at the University of Colorado Anschutz School of Medicine. Forward-looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The terms "lasting," "long-term," and "enduring" refer to being able to control IOP for years with one procedure compared to current eye drops, which require dosing daily or even more frequently. All statements in this press release that are not purely historical are forward-looking statements, including, but not limited to, statements regarding: the potential benefits and impact of the BIM-IOL System and BIM-DRS on patients, including the potential of BIM-DRS to provide lasting IOP reduction to every pseudophakic glaucoma patient, the size of the addressable patient population, the timing of growth of such patient population, the potential of the BIM-IOL System and BIM-DRS to provide long-term, drop-free glaucoma treatment and sustained visual protection, the anticipated presentation of additional clinical data, including the timing of such additional data, SpyGlass Pharma’s plans relating to the Phase 3 clinical development of the BIM-IOL System, including the timing of expected completion of enrollment, and to the clinical development of the BIM-DRS, including the timing of initiation of the first-in-human trial, the potential commercial launch, market adoption and reimbursement under CPT codes after FDA approval of the BIM-IOL System, the belief that the dedicated reimbursement pathway for surgeons could accelerate commercial adoption of the BIM-IOL System, and the sufficiency of cash, cash equivalents and short-term investments and SpyGlass Pharma’s expectation to fund planned operations through 2028. The forward-looking statements contained herein are based upon SpyGlass Pharma’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including those set forth in the Risk Factors section of the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2026 filed with the Securities and Exchange Commission on August 6, 2026, and in similar disclosures set forth in the other documents that SpyGlass Pharma has filed and may file from time to time with the SEC. These forward-looking statements are made as of the date of this press release, and SpyGlass Pharma assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. SpyGlass Pharma’s views in these forward-looking statements should not be relied as representing the Company’s views as of any date subsequent to the date of this press release. Media Contact:Nami Surendranath+1 (402) [email protected] Investor Contact:Ami Bavishi or Nick ColangeloGilmartin Group [email protected]
Investor releaseQuarter not tagged2026-05-15SpyGlass Pharma Reports First Quarter 2026 Financial Results and Provides Corporate Updates
GlobeNewswire
SpyGlass Pharma Reports First Quarter 2026 Financial Results and Provides Corporate Updates
Enrollment remains on track in the registrational Phase 3 trials of the Bimatoprost Drug Pad-IOL System (BIM-IOL System), with completion of enrollment expected in 2027. Topline 12-month data from the BIM-IOL System Phase 1/2 trial demonstrated elimination of IOP-lowering topical eye drops for 98% of trial participants and 34% mean intraocular pressure (IOP) reduction from baseline at the intended commercial dose of 78-mcg, and all patients achieving best-corrected distance visual acuity (BCDVA) on par with state-of-the-art monofocal IOLs in the control group at 20/32 or better with a mean BCDVA equivalent to 20/20. Bimatoprost-Drug Ring System (BIM-DRS) first-in-human trial is on track to start in the second half of 2026. Cash, cash equivalents and short-term investments of $251.0 million on March 31, 2026, are expected to fund planned operations through 2028. ALISO VIEJO, Calif., May 14, 2026 (GLOBE NEWSWIRE) -- SpyGlass Pharma, Inc. (Nasdaq: SGP) (“SpyGlass Pharma” or “Company”), a late-stage biopharmaceutical company, today reported recent business highlights and financial results for the first quarter ended March 31, 2026. “Following the successful completion of our IPO in February, SpyGlass Pharma is in a strong financial position to complete the development of its sustained release, intraocular delivery of bimatoprost via our BIM-IOL System at the time of cataract surgery in patients with glaucoma. The benefit of potential freedom from daily eye drops for patients is immense, and the BIM-IOL System enables every cataract surgeon to integrate durable, sustained glaucoma care at the time of cataract surgery, with no new surgical techniques required,” stated Patrick Mooney, chief executive officer of SpyGlass Pharma. “We remain highly focused on the enrollment of our registrational Phase 3 trials and the initiation of our first-in-human study of our BIM-DRS, which we expect to occur in the second half of 2026. BIM-DRS has the potential to reach all glaucoma and OHT patients, even if they have already had cataract surgery, and enable lifetime retreatment.” BIM-IOL System Program Highlights 12-Month Phase 1/2 Data of BIM-IOL System. In March 2026, SpyGlass Pharma announced positive topline results from its Phase 1/2 trial of the BIM-IOL System, to lower IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) and a concomitant cataract.…Read full documentShow less
Enrollment remains on track in the registrational Phase 3 trials of the Bimatoprost Drug Pad-IOL System (BIM-IOL System), with completion of enrollment expected in 2027. Topline 12-month data from the BIM-IOL System Phase 1/2 trial demonstrated elimination of IOP-lowering topical eye drops for 98% of trial participants and 34% mean intraocular pressure (IOP) reduction from baseline at the intended commercial dose of 78-mcg, and all patients achieving best-corrected distance visual acuity (BCDVA) on par with state-of-the-art monofocal IOLs in the control group at 20/32 or better with a mean BCDVA equivalent to 20/20. Bimatoprost-Drug Ring System (BIM-DRS) first-in-human trial is on track to start in the second half of 2026. Cash, cash equivalents and short-term investments of $251.0 million on March 31, 2026, are expected to fund planned operations through 2028. ALISO VIEJO, Calif., May 14, 2026 (GLOBE NEWSWIRE) -- SpyGlass Pharma, Inc. (Nasdaq: SGP) (“SpyGlass Pharma” or “Company”), a late-stage biopharmaceutical company, today reported recent business highlights and financial results for the first quarter ended March 31, 2026. “Following the successful completion of our IPO in February, SpyGlass Pharma is in a strong financial position to complete the development of its sustained release, intraocular delivery of bimatoprost via our BIM-IOL System at the time of cataract surgery in patients with glaucoma. The benefit of potential freedom from daily eye drops for patients is immense, and the BIM-IOL System enables every cataract surgeon to integrate durable, sustained glaucoma care at the time of cataract surgery, with no new surgical techniques required,” stated Patrick Mooney, chief executive officer of SpyGlass Pharma. “We remain highly focused on the enrollment of our registrational Phase 3 trials and the initiation of our first-in-human study of our BIM-DRS, which we expect to occur in the second half of 2026. BIM-DRS has the potential to reach all glaucoma and OHT patients, even if they have already had cataract surgery, and enable lifetime retreatment.” BIM-IOL System Program Highlights 12-Month Phase 1/2 Data of BIM-IOL System. In March 2026, SpyGlass Pharma announced positive topline results from its Phase 1/2 trial of the BIM-IOL System, to lower IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) and a concomitant cataract. The trial compared BIM-IOL System at the intended commercial dose of 78-mcg (N=51), and 39-mcg (N=23) compared to a physician's choice of commercially available monofocal IOLs from Alcon, Bausch + Lomb or Johnson & Johnson with twice-daily administration of timolol eyedrops as the control group (N=30). For SpyGlass Pharma’s intended commercial dose of 78-mcg, patients receiving the BIM-IOL System achieved robust clinical improvement: A mean, time-matched IOP reduction from baseline of 34%. 98% of evaluable BIM-IOL patients were free from all topical IOP-lowering medications. 100% of evaluable patients achieved 20/32 or better best corrected distance visual acuity (BCDVA). Mean BCDVA equivalent to 20/20 vision (86 letters), demonstrating a vision performance profile in line with the state-of-the-art IOLs in the control group. The BIM-IOL System was well tolerated and exhibited a safety profile comparable to routine cataract surgery, with no serious adverse events observed. SpyGlass Pharma anticipates presenting additional Phase 1/2 trial results at a future medical meeting. First Surgeries Completed in Parallel Phase 3 BIM-IOL System Trials. The two registrational Phase 3 trials, SGP-005 and SGP-006, are designed to demonstrate non-inferiority of the BIM-IOL System to a state-of-the-art commercial IOL with twice-daily topical timolol. SpyGlass Pharma continues to expect that both trials will complete enrollment in 2027. Corporate Highlights Completion of Initial Public Offering. In February 2026, SpyGlass Pharma completed its initial public offering, including the full exercise of the underwriters’ over-allotment option, raising approximately $172.5 million in gross proceeds and funding planned operations through 2028. First Quarter 2026 Financial Results Cash, Cash Equivalents and Short-Term Investments totaled $251.0 million as of March 31, 2026. Research and Development Expenses were $8.5 million for the first quarter of 2026, compared to $6.1 million for the first quarter of 2025. The increase was primarily due to the hiring of clinical personnel. General and Administrative Expenses were $6.9 million for the first quarter of 2026, compared to $1.4 million for the first quarter of 2025. The increase was primarily due to higher professional services and personnel. Net Loss was $13.8 million, or ($0.69) per basic and diluted share, for the first quarter of 2026, compared to $8.8 million, or ($3.96) per basic and diluted share, for same period of 2025. Upcoming Milestones BIM-DRS: Initiation of the FIH trial in the second half of 2026. BIM-IOL System: Four-year efficacy and safety follow-up expected in fourth quarter of 2026. About the Bimatoprost Drug Pad-IOL System SpyGlass Pharma’s lead product candidate, the Bimatoprost Drug Pad-IOL System (BIM-IOL System), comprising novel, proprietary non-bioerodible drug pads attached to its intraocular lens, was designed to be implanted during routine cataract surgery to reduce elevated intraocular pressure (IOP) in patients who have either open-angle glaucoma (OAG) or ocular hypertension (OHT). The BIM-IOL System is designed to consistently deliver three years of bimatoprost, a prostaglandin analog approved for topical use by the U.S. Food and Drug Administration (FDA) in 2001, for the reduction of elevated IOP in patients with OAG or OHT. The company initiated two registrational Phase 3 clinical trials of the BIM-IOL System and continues long-term follow-up of patients in the Phase 1/2 study investigating the safety and efficacy of the BIM-IOL System. SpyGlass Pharma plans to work with the FDA to advance the program through completion of Phase III clinical trials, New Drug Application submission, and ultimately to potential FDA approval. About SpyGlass Pharma SpyGlass Pharma is a late-stage biopharmaceutical company dedicated to transforming the treatment paradigm for patients living with chronic eye conditions through long-acting, sustained drug delivery of approved medicines. The Company’s mission is to significantly improve the lives of patients with chronic eye conditions by developing durable drug delivery solutions that can empower patients and surgeons with confidence in long-term disease control and vision preservation. The SpyGlass Pharma platform, a novel, non-bioerodible drug delivery technology, is designed to be used with various well-established, approved medicines, including bimatoprost and other small molecules, providing flexibility to potentially treat a range of conditions in the front and back of the eye. The Company was founded in 2019 by Malik Y. Kahook, M.D. and Glenn Sussman to solve the lack of ophthalmic innovations that capitalize on durable treatment options. The SpyGlass Pharma platform was originally developed in the Sue Anschutz-Rodgers Eye Center at the University of Colorado Anschutz School of Medicine. Forward-looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements in this press release that are not purely historical are forward-looking statements, including, but not limited to, statements regarding: the potential benefits and impact of the BIM-IOL System on patients, anticipated presentation of additional clinical data, including the four-year data from the FIH trial for the BIM-IOL System, the initiation of the FIH trial for BIM-DRS, SpyGlass Pharma’s cash runway, and SpyGlass Pharma’s plans relating to the clinical development of the BIM-IOL System toward commercial launch after FDA approval, including enrollment completion timing. The forward-looking statements contained herein are based upon SpyGlass Pharma’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including those set forth in the Risk Factors section of the Company’s Quarterly Report on Form 10-Q for the three-month period ended March 31, 2026 filed with the Securities and Exchange Commission on or about the date hereof, and in similar disclosures set forth in the other documents that SpyGlass Pharma may file from time to time with the SEC. These forward-looking statements are made as of the date of this press release, and SpyGlass Pharma assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. SpyGlass Pharma’s views in these forward-looking statements should not be relied as representing the Company’s views as of any date subsequent to the date of this press release. Media Contact: Nami Surendranath +1 (402) 507-6757 [email protected] Investor Contact: Ami Bavishi or Nick Colangelo Gilmartin Group LLC [email protected]
Investor releaseQuarter not tagged2026-03-27SpyGlass Pharma Reports Fourth Quarter and Full Year 2025 Earnings and Provides a Corporate Update
GlobeNewswire
SpyGlass Pharma Reports Fourth Quarter and Full Year 2025 Earnings and Provides a Corporate Update
Successfully completed Initial Public Offering (IPO) in February 2026, raising $172.5 million and listing on Nasdaq. Reported positive topline 12-month data from Phase 1/2 trial of the Bimatoprost Drug Pad-IOL System (BIM-IOL System) that demonstrated sustained intraocular pressure (IOP) control, elimination of IOP-lowering eye drops for 97% of trial participants, and improved visual performance, with a favorable safety profile. Phase 3 trials of BIM-IOL System are ongoing, with enrollment underway and full enrollment expected in 2027. Cash, cash equivalents and short-term investments expected to fund planned operations through 2028. ALISO VIEJO, Calif., March 26, 2026 (GLOBE NEWSWIRE) -- SpyGlass Pharma, Inc. (Nasdaq: SGP) (“SpyGlass Pharma” or “Company”), a late-stage biopharmaceutical company, today reported recent business highlights and financial results for the fourth quarter and year ended December 31, 2025. “2025 was an important year for SpyGlass, as we advanced the development of our BIM-IOL System, including the initiation of two Phase 3 trials. We look forward to bringing our innovative technology to more patients and more surgeons,” stated Patrick Mooney, chief executive officer of SpyGlass Pharma. “2026 is off to an exceptional start, highlighted by our successful IPO that funds the Phase 3 trials of the BIM-IOL System as well as the planned initiation of a first-in-human trial of the Bimatoprost Drug Ring System (BIM-DRS), which potentially expands our market opportunity. We remain deeply focused on delivering long-term, eye drop-free therapy for the approximately one million glaucoma and ocular hypertension patients who undergo cataract surgery in the United States each year.” BIM-IOL System Program Highlights 12-Month Phase 1/2 Data of BIM-IOL System. In March 2026, SpyGlass Pharma announced positive topline results from its Phase 1/2 trial of the BIM-IOL System, which evaluated two dose levels of 78-mcg (N=51), the intended commercial dose, and 39-mcg (N=23) compared to a physician's choice of commercially available monofocal IOLs from Alcon, Bausch + Lomb or Johnson & Johnson with twice-daily administration of timolol eyedrops as the control group (N=30). Evaluable patients receiving the BIM-IOL System achieved a time-matched reduction of 34% and 42% in mean IOP from baseline in the high and low dose groups respectively, compared to a 35%…Read full documentShow less
Successfully completed Initial Public Offering (IPO) in February 2026, raising $172.5 million and listing on Nasdaq. Reported positive topline 12-month data from Phase 1/2 trial of the Bimatoprost Drug Pad-IOL System (BIM-IOL System) that demonstrated sustained intraocular pressure (IOP) control, elimination of IOP-lowering eye drops for 97% of trial participants, and improved visual performance, with a favorable safety profile. Phase 3 trials of BIM-IOL System are ongoing, with enrollment underway and full enrollment expected in 2027. Cash, cash equivalents and short-term investments expected to fund planned operations through 2028. ALISO VIEJO, Calif., March 26, 2026 (GLOBE NEWSWIRE) -- SpyGlass Pharma, Inc. (Nasdaq: SGP) (“SpyGlass Pharma” or “Company”), a late-stage biopharmaceutical company, today reported recent business highlights and financial results for the fourth quarter and year ended December 31, 2025. “2025 was an important year for SpyGlass, as we advanced the development of our BIM-IOL System, including the initiation of two Phase 3 trials. We look forward to bringing our innovative technology to more patients and more surgeons,” stated Patrick Mooney, chief executive officer of SpyGlass Pharma. “2026 is off to an exceptional start, highlighted by our successful IPO that funds the Phase 3 trials of the BIM-IOL System as well as the planned initiation of a first-in-human trial of the Bimatoprost Drug Ring System (BIM-DRS), which potentially expands our market opportunity. We remain deeply focused on delivering long-term, eye drop-free therapy for the approximately one million glaucoma and ocular hypertension patients who undergo cataract surgery in the United States each year.” BIM-IOL System Program Highlights 12-Month Phase 1/2 Data of BIM-IOL System. In March 2026, SpyGlass Pharma announced positive topline results from its Phase 1/2 trial of the BIM-IOL System, which evaluated two dose levels of 78-mcg (N=51), the intended commercial dose, and 39-mcg (N=23) compared to a physician's choice of commercially available monofocal IOLs from Alcon, Bausch + Lomb or Johnson & Johnson with twice-daily administration of timolol eyedrops as the control group (N=30). Evaluable patients receiving the BIM-IOL System achieved a time-matched reduction of 34% and 42% in mean IOP from baseline in the high and low dose groups respectively, compared to a 35% reduction in the control group at 8 a.m. Results were similar at the 10 a.m. timepoint. Additionally, 98% of evaluable patients (48 of 49) in the 78-mcg dose group and 96% of evaluable patients (22 of 23) in the 39-mcg dose group were free from all topical IOP-lowering medications 12 months after surgery. The BIM-IOL System demonstrated improved visual performance, in line with the control group with 100% (72 of 72) of trial participants receiving the BIM-IOL System reaching 20/32 or better best corrected distance visual acuity (BCDVA), and mean BCDVA of 86 letters, which is equivalent to 20/20 vision. The BIM-IOL System was well tolerated and exhibited a safety profile comparable to routine cataract surgery, with no serious ocular adverse events (AEs) observed. SpyGlass Pharma anticipates presenting additional Phase 1/2 trial results at a future medical meeting. First Patients Randomized and First Surgeries Completed in Phase 3 Trials. In January 2026, SpyGlass Pharma announced that it randomized the first patients in SGP-005 and SGP-006, the Company’s two registrational Phase 3 clinical trials to demonstrate non-inferiority of the BIM-IOL System in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) undergoing cataract surgery compared to a standard of care, commercially available IOL with twice-daily administration of timolol eye drops. The co-primary endpoints are the time-matched change in mean IOP from baseline, as well as the proportion of patients achieving BCDVA of 20/40 or better. 36-Month First-in-Human (FIH) Data of BIM-IOL System. In November 2025, at the Interventional Glaucoma Consortium Meeting, SpyGlass Pharma announced 36-month follow-up data from its FIH study of the BIM-IOL System, demonstrating a 37% reduction in mean IOP across all dose groups and reporting that 95% of patients were off all topical IOP-lowering drops. Additionally, 100% of evaluable patients achieved 20/30 or better BCDVA. No product-related AEs were reported. Presentation at Premier Interventional Glaucoma Medical Meeting. In February 2026, Dr. Nathan Radcliffe, a seasoned glaucoma and cataract surgeon at the New York Eye Surgery Center and member of SpyGlass Pharma’s medical advisory board, presented data generated to date in the FIH and Phase 1/2 trials of the BIM-IOL System and an overview of SGP-005 and SGP-006’s trial designs at the Glaucoma Innovation Summit (GIS) at the American Glaucoma Society’s 2026 Annual Meeting. Corporate Highlights Completion of Initial Public Offering. On February 9, 2026, SpyGlass Pharma closed its initial public offering, raising approximately $172.5 million in gross proceeds, including the full exercise of the underwriters’ option to purchase additional shares. Strengthened Leadership. In February 2026, upon completion of its IPO, SpyGlass Pharma enhanced its board of directors with the appointment of independent director Habib Dable, who has over 30 years of industry experience, of which ten were in the ophthalmology pharmaceutical buy-and-bill space, and currently serves as an advisor at RA Capital Management. Additionally, in January 2026, SpyGlass Pharma appointed Jean-Frédéric Viret, Ph.D., as chief financial officer. Dr. Viret has over two decades of experience in life sciences and corporate finance with commercial late-stage clinical development companies. Fourth Quarter and Full Year 2025 Financial Results Cash, Cash Equivalents and Short-Term Investments totaled $107.4 million as of December 31, 2025. This balance excludes proceeds from the Company’s initial public offering of $172.5 million before associated underwriting discounts, commissions and other offering costs. With the IPO proceeds, SpyGlass Pharma expects its current cash position to fund planned operations through 2028. Research and Development Expenses were $7.7 million for the fourth quarter of 2025 and $29.2 million for the year ended December 31, 2025, compared to $5.7 million and $20.0 million, respectively, for the same periods of 2024. The increase was primarily due to the hiring of clinical and research personnel and the initiation of the registrational Phase 3 trials of the BIM-IOL System. General and Administrative Expenses were $5.9 million for the fourth quarter of 2025 and $12.3 million for the year ended December 31, 2025, compared to $2.0 million and $7.1 million, respectively, for the same periods of 2024. The increase was primarily due to higher professional services and personnel. Net Loss was $12.6 million, or ($5.72) per basic and diluted share, for the fourth quarter of 2025, compared to $8.4 million, or ($4.58) per basic and diluted share, for the fourth quarter of 2024. Net loss for the year ended December 31, 2025 was $39.9 million, or ($17.98) per basic and diluted share, compared to $29.2 million, or ($16.31) per basic and diluted share, for the year ended December 31, 2024. Upcoming Milestones BIM-DRS: Initiation of the FIH trial in the second half of 2026. BIM-IOL: Four-year efficacy and safety follow-up on the FIH trial in fourth quarter of 2026. About SpyGlass Pharma SpyGlass Pharma is a late-stage biopharmaceutical company dedicated to transforming the treatment paradigm for patients living with chronic eye conditions through long-acting, sustained drug delivery of approved medicines. The company’s mission is to significantly improve the lives of patients with chronic eye conditions by developing durable drug delivery solutions that can empower patients and surgeons with confidence in long-term disease control and vision preservation. The SpyGlass Pharma platform, a novel, non-bioerodible drug delivery technology, is designed to be used with various well-established, approved medicines, including bimatoprost and other small molecules, providing flexibility to potentially treat a range of conditions in the front and back of the eye. The company was founded in 2019 by Malik Y. Kahook, M.D. and Glenn Sussman to solve the lack of ophthalmic innovations that capitalize on durable treatment options. The SpyGlass Pharma platform was originally developed in the Sue Anschutz-Rodgers Eye Center at the University of Colorado Anschutz School of Medicine. Forward-looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements in this press release that are not purely historical are forward-looking statements, including, but not limited to, statements regarding: the potential benefits and impact of the BIM-IOL System on patients, anticipated presentation of additional clinical data, the initiation of the FIH trial for BIM-DRS, SpyGlass Pharma’s cash runway, the reporting of the four-year data from the BIM-IOL FIH trial, and SpyGlass Pharma’s plans relating to the clinical development of the BIM-IOL System toward commercial approval, including enrollment completion timing. The forward-looking statements contained herein are based upon SpyGlass Pharma’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including those set forth in the Risk Factors section of the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2025 filed with the Securities and Exchange Commission on or about the date hereof, and in similar disclosures set forth in the other documents that SpyGlass Pharma has filed and may file from time to time with the SEC, including the final IPO prospectus filed on February 6, 2026. These forward-looking statements are made as of the date of this press release, and SpyGlass Pharma assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. SpyGlass Pharma’s views in these forward-looking statements should not be relied as representing the Company’s views as of any date subsequent to the date of this press release. Media Contact: Nami Surendranath +1 (402) 507-6757 [email protected] Investor Contact: Ami Bavishi or Nick Colangelo Gilmartin Group LLC [email protected]
Investor releaseQuarter not tagged2026-03-09SpyGlass Pharma Announces Positive Topline 12-Month Phase 1/2 Trial Results for Its Innovative BIM-IOL System
GlobeNewswire
SpyGlass Pharma Announces Positive Topline 12-Month Phase 1/2 Trial Results for Its Innovative BIM-IOL System
97% of patients who received the BIM-IOL System off all topical IOP-lowering therapy at 12-months 100% of BIM-IOL System patients achieved 20/32 or better BCDVA and a mean BCDVA equivalent to 20/20 vision, demonstrating high quality of vision, performance in line with the state-of-the-art IOLs in the control group Overall safety results were comparable to routine cataract surgery ALISO VIEJO, Calif., March 09, 2026 (GLOBE NEWSWIRE) -- SpyGlass Pharma, Inc. (Nasdaq: SGP) (SpyGlass Pharma), a late-stage biopharmaceutical company, today announced positive 12-month results from the Phase 1/2 trial evaluating its lead product candidate, the Bimatoprost Drug Pad-IOL System (BIM-IOL System), for the treatment of elevated intraocular pressure (IOP) in patients previously diagnosed with open-angle glaucoma (OAG) or ocular hypertension (OHT) and a concomitant cataract. A total of 104 patients were randomized 2:1:1 to receive the 78 mcg BIM-IOL System (N=51) and 39 mcg BIM-IOL System (N=23) with daily administration of artificial tear drops, or a commercially available monofocal IOL from Alcon, Bausch + Lomb or Johnson & Johnson with twice-daily administration of timolol eye drops as the control group (N=30). At 12 months, the BIM-IOL System achieved: Evaluable patients achieved a 34% and 42% reduction in mean IOP from baseline in the 78-mcg and 39-mcg dose groups, respectively, compared to a 35% reduction in the control group at 8 a.m. Results were similar at the 10 a.m. timepoint. 98% of evaluable patients (48 of 49) in the 78-mcg dose group and 96% of evaluable patients (22 of 23) in the 39-mcg dose group were free from all topical IOP-lowering medications. Evaluable patients (N=72) demonstrated vision improvement, 100% reaching 20/32 or better best corrected distance visual acuity (BCDVA) and mean BCDVA of 86 letters (equivalent to 20/20 vision). Adverse event (AE) rates were similar across the 78-mcg (41.2%), 39-mcg (43.5%), and control (36.7%) groups. No serious ocular AEs were observed. “The 12-month results demonstrate the potential for the BIM-IOL System to address the key challenge of long-term adherence to ophthalmic treatments, delivering sustained IOP reduction and improved visual performance while eliminating the need for topical drops,” said Malik Kahook, M.D., chief medical officer and executive chair of the board of SpyGlass Pharma. “These positive fin…Read full documentShow less
97% of patients who received the BIM-IOL System off all topical IOP-lowering therapy at 12-months 100% of BIM-IOL System patients achieved 20/32 or better BCDVA and a mean BCDVA equivalent to 20/20 vision, demonstrating high quality of vision, performance in line with the state-of-the-art IOLs in the control group Overall safety results were comparable to routine cataract surgery ALISO VIEJO, Calif., March 09, 2026 (GLOBE NEWSWIRE) -- SpyGlass Pharma, Inc. (Nasdaq: SGP) (SpyGlass Pharma), a late-stage biopharmaceutical company, today announced positive 12-month results from the Phase 1/2 trial evaluating its lead product candidate, the Bimatoprost Drug Pad-IOL System (BIM-IOL System), for the treatment of elevated intraocular pressure (IOP) in patients previously diagnosed with open-angle glaucoma (OAG) or ocular hypertension (OHT) and a concomitant cataract. A total of 104 patients were randomized 2:1:1 to receive the 78 mcg BIM-IOL System (N=51) and 39 mcg BIM-IOL System (N=23) with daily administration of artificial tear drops, or a commercially available monofocal IOL from Alcon, Bausch + Lomb or Johnson & Johnson with twice-daily administration of timolol eye drops as the control group (N=30). At 12 months, the BIM-IOL System achieved: Evaluable patients achieved a 34% and 42% reduction in mean IOP from baseline in the 78-mcg and 39-mcg dose groups, respectively, compared to a 35% reduction in the control group at 8 a.m. Results were similar at the 10 a.m. timepoint. 98% of evaluable patients (48 of 49) in the 78-mcg dose group and 96% of evaluable patients (22 of 23) in the 39-mcg dose group were free from all topical IOP-lowering medications. Evaluable patients (N=72) demonstrated vision improvement, 100% reaching 20/32 or better best corrected distance visual acuity (BCDVA) and mean BCDVA of 86 letters (equivalent to 20/20 vision). Adverse event (AE) rates were similar across the 78-mcg (41.2%), 39-mcg (43.5%), and control (36.7%) groups. No serious ocular AEs were observed. “The 12-month results demonstrate the potential for the BIM-IOL System to address the key challenge of long-term adherence to ophthalmic treatments, delivering sustained IOP reduction and improved visual performance while eliminating the need for topical drops,” said Malik Kahook, M.D., chief medical officer and executive chair of the board of SpyGlass Pharma. “These positive findings from a multicenter, randomized, controlled clinical trial reinforce our previously released 3-year first-in-human data. We look forward to presenting additional Phase 1/2 trial results at a future medical conference.” “This readout clearly demonstrates the potential for SpyGlass technology to have a life changing impact on patients, while being accessible to 100% of cataract surgeons. We’re now in a category of our own in demonstrating our ability to eliminate topical IOL-lowering medications for the vast majority of patients, while delivering the same high quality of vision that patients and surgeons expect from state-of-the-art IOLs,” said Patrick Mooney, chief executive officer of SpyGlass Pharma. “Bolstered by our confidence in the Phase 1/2 program, we remain hyper-focused on advancing enrollment for our two pivotal Phase 3 trials of the BIM-IOL System.” In January 2026, SpyGlass Pharma announced that the first patients were randomized in two identical registrational Phase 3 trials of the 78-mcg dose of the BIM-IOL System. The Phase 3 trials are largely consistent in trial design with the SpyGlass Pharma Phase 1/2 trial with minor protocol modifications intended to improve consistency across trial arms. About the Phase 1/2 Trial The Phase 1/2 trial is a prospective, multicenter, randomized, double-masked, controlled clinical trial evaluating the safety and efficacy of the innovative BIM-IOL System in patients with OAG or OHT undergoing cataract surgery. A total of 104 evaluable patients were randomized 2:1:1 to receive the 78 mcg BIM-IOL System (N=51) with daily administration of artificial tear drops, 39 mcg BIM-IOL System (N=23) with daily administration of artificial tear drops, or a commercially available monofocal IOL with twice-daily administration of timolol eye drops as the control group (N=30). The primary endpoint is mean IOP reduction from baseline at two time points for each follow-up visit at the 2 Weeks, 6 Weeks, and 3 Months. Secondary endpoints include mean IOP reduction from baseline, mean IOP, time to reintroduction and number of IOP-lowering medications, and improvement of visual performance. The trial also includes typical safety assessments for both medication and IOL. About the Bimatoprost Drug Pad-IOL System SpyGlass Pharma’s lead product candidate, the Bimatoprost Drug Pad-IOL System (BIM-IOL System), comprising novel, proprietary non-bioerodible drug pads attached to its intraocular lens, was designed to be implanted during routine cataract surgery to reduce elevated intraocular pressure (IOP) in patients who have either open-angle glaucoma (OAG) or ocular hypertension (OHT). The BIM-IOL System is designed to consistently deliver multiple years of bimatoprost, a prostaglandin analog approved for topical use by the U.S. Food and Drug Administration (FDA) in 2001, for the reduction of elevated IOP in patients with OAG or OHT. The company continues long-term follow-up of patients in both the first-in-human trial and Phase 1/2 trial as well as patient enrollment in ongoing Phase 3 clinical trials. SpyGlass plans to work with the FDA to advance the program through 505(b)(2) New Drug Application (NDA) submission and ultimately to potential commercial approval. About SpyGlass Pharma SpyGlass Pharma is a late-stage biopharmaceutical company dedicated to transforming the treatment paradigm for patients living with chronic eye conditions through long-acting, sustained drug delivery of approved medicines. The company’s mission is to significantly improve the lives of patients with chronic eye conditions by developing durable drug delivery solutions that can empower patients and surgeons with confidence in long-term disease control and vision preservation. The SpyGlass Pharma platform, a novel, non-bioerodible drug delivery technology, is designed to be used with various well-established, approved medicines, including bimatoprost and other small molecules, providing flexibility to potentially treat a range of conditions in the front and back of the eye. The company was founded in 2019 by Malik Y. Kahook, M.D. and Glenn Sussman to solve the lack of ophthalmic innovations that capitalize on durable treatment options. The SpyGlass Pharma platform was originally developed in the Sue Anschutz-Rodgers Eye Center at the University of Colorado Anschutz School of Medicine. FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements in this press release that are not purely historical are forward-looking statements, including, but not limited to, statements regarding: the potential benefits and impact of the BIM-IOL System on patients, anticipated presentation of additional data, and SpyGlass Pharma’s plans relating to the clinical development of the BIM-IOL System towards commercial approval. The forward-looking statements contained herein are based upon SpyGlass Pharma’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including those set forth in the Risk Factors section of the Company’s final 424B4 prospectus filed with the Securities and Exchange Commission (SEC) on February 6, 2026, and the other documents that SpyGlass Pharma may file from time to time with the SEC. These forward-looking statements are made as of the date of this press release, and SpyGlass Pharma assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Media Contact: Nami Surendranath (402) 507-6757 [email protected] Investor Contact: Ami Bavishi or Nick Colangelo Gilmartin Group LLC [email protected]

