EyePoint Announces Positive Recommendation for Pivotal Phase 3 Trials for Duravyu

EyePoint Pharmaceuticals announced that the independent Data Safety Monitoring Committee (DSMC) completed its second review of the company’s ongoing pivotal phase 3 program evaluating Duravyu for the treatment of wet AMD, recommending that both the LUGANO and LUCIA trials continue as planned, with no protocol modifications. All patients across the LUGANO and LUCIA trials have reached the week 8 visit during which patients in the treatment arms received their initial Duravyu dose, and approximately 25% of those patients received their second planned dose of the study drug at week 32.

“We are pleased to receive our second consecutive positive recommendation from the DSMC for our pivotal wet AMD program. Now that all patients are past initial dosing and a growing number have received redosing, this recommendation strengthens our confidence in Duravyu’s consistent, favorable safety profile observed across its robust development history,” said Ramiro Ribeiro, MD, PhD, chief medical officer at EyePoint. “As we advance toward topline data starting in mid-2026, we remain focused on continued clinical trial execution and regulatory preparedness to support our ultimate goal of delivering Duravyu to patients as expeditiously as possible.”

Enrollment is complete in LUGANO and LUCIA, randomized, double-masked, aflibercept (Eylea, Regeneron) controlled, non-inferiority phase 3 trials assessing the efficacy and safety of Duravyu in treatment-naïve and treatment-experienced patients with active wet AMD. The primary endpoint of the phase 3 pivotal trials is noninferiority in the average change in BCVA at weeks 52 and 56 compared with baseline. Secondary endpoints include safety, reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections, and anatomical results as measured by OCT.