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Ocular Therapeutix™ Announces More Than 300 Subjects Randomized in SOL-1
SOL-1 is the first registrational trial for AXPAXLI™ in wet AMD Topline clinical data from SOL-1 expected in Q4 2025 Active clinical trial sites enrolling
About this update from Ocular Therapeutix, Inc.
[{"type":"text","content":"SOL-1 is the first registrational trial for AXPAXLI™ in wet AMD Topline clinical data from SOL-1 expected in Q4 2025 Active clinical trial sites enrolling patients directly into second registrational trial, SOL-R, while additional sites continue to be activated BEDFORD, Mass., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to improving vision in the real world through the development and commercialization of innovative therapies for retinal diseases and other eye conditions, today announced that more than 300 patients have been randomized in the SOL-1 Phase 3 trial for AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI), and the trial is expected to close randomization this week. This is the first registrational clinical trial of AXPAXLI in wet age-related macular degeneration (wet AMD), which remains on track to report topline data in the fourth quarter of 2025. “SOL-1 reaching target randomization in 2024 is a landmark event for Ocular. SOL-1 is an important trial for patients and the retina community as there is an urgent unmet need for durable therapies capable of maintaining visual acuity and improving long-term outcomes. Today’s milestone brings us one step closer to our goal of delivering the first wet AMD therapy potentially capable of being dosed as infrequently as every six to nine months. Achieving this progress reflects our positive engagement with the retina community, the dedication of our clinical sites, and the demand for a durable treatment option for wet AMD,” said Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix. Dr. Dugel continued, “Thanks to the excellent momentum from SOL-1, we recently ‘flipped the switch’, allowing active clinical sites to enroll patients directly into our second registrational study in wet AMD, SOL-R, further accelerating its pace of enrollment. Thanks to the palpable enthusiasm from the investigators and study site teams, we continue to make excellent progress with the enrollment of SOL-R, with a steady focus on our overall mission of improving vision for patients.” Ocular’s second registrational clinical trial, the SOL-R repeat dosing trial, has benefited from the recruitment momentum of SOL-1. Earlier this quarter, Ocular allowed i...