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EyePoint Announces Third Consecutive Positive DSMC Recommendation for Phase 3 Wet AMD Trials for DURAVYU™, Building Confidence Ahead of Mid-2026 Topline Data
– LUGANO topline data on track for mid-2026, with LUCIA readout to follow shortly after – – Continued favorable safety profile observed in masked Phase 3
About this update from Eyepoint, Inc.
– LUGANO topline data on track for mid-2026, with LUCIA readout to follow shortly after – – Continued favorable safety profile observed in masked Phase 3 DURAVYU data, consistent with four previously completed clinical trials – – All active patients in the treatment arm have reached their second DURAVYU dosing visit, with over 35% receiving a third dose – WATERTOWN, Mass., May 14, 2026 (GLOBE NEWSWIRE) -- EyePoint, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced that the independent Data Safety Monitoring Committee (DSMC) completed its third scheduled review of the Company’s pivotal Phase 3 program evaluating DURAVYU for wet age-related macular degeneration (wet AMD) and recommended that both the LUGANO and LUCIA trials continue as planned with no protocol modifications. As of May 2, 2026, all active patients in the treatment arm have reached the Week 32 visit, during which patients received their second DURAVYU dose. Over 35% of those patients have also received their third planned dose at Week 56. Interim masked safety data from the Phase 3 trials show a continued favorable safety profile for DURAVYU, consistent with the safety observed in over 190 patients across four completed clinical trials. The DSMC is an independent panel of experts in ophthalmology and biostatistics who are responsible for reviewing safety data to ensure the welfare of trial participants and to provide recommendations regarding trial conduct. DSMC meetings are scheduled to occur every six months per the trial protocol, and this is the last anticipated DSMC meeting ahead of topline data. “Safety is paramount in retinal disease therapies, and receiving three consecutive positive DSMC recommendations to continue our Phase 3 wet AMD trials without modification reflects the consistency of DURAVYU’s safety profile and the rigor of our Phase 3 wet AMD program design,” said Ramiro Ribeiro, M.D., Ph.D., Chief Medical Officer at EyePoint. “This continued independent validation, together with the favorable safety profile observed across four completed clinical trials, reinforces our confidence as we approach Phase 3 topline data beginning in mid-2026. If successful, we believe that DURAVYU is well-positioned to be a first and best-in-class therapy with the poten...