EyePoint receives positive DSMC recommendation for Duravyu Phase 3 trials

EyePoint (EYPT) announced the independent data safety monitoring committee completed its third scheduled review of the company’s pivotal Phase 3 program evaluating Duravyu for wet age-related macular degeneration, recommending both the LUGANO and LUCIA trials continue as planned with no protocol modifications. Interim masked safety data show a continued favorable safety profile, consistent with safety observed in over 190 patients across four completed clinical trials. As of May 2, all active patients in the treatment arm have reached the Week 32 visit, receiving their second DURAVYU dose, with over 35% also receiving a third planned dose at Week 56. LUGANO topline data is on track for mid-2026, with LUCIA to follow shortly after; this is the last anticipated committee review 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, chief medical officer.