SGP

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....

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%...

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...