EyePoint Announces Positive Recommendation for Pivotal Phase 3 Trials of Duravyu

EyePoint Pharmaceuticals announced that the independent Data Safety Monitoring Committee (DSMC) has completed its second review of the company’s ongoing pivotal phase 3 program evaluating Duravyu for the treatment of wet age-related macular degeneration (AMD). The committee recommended that both the LUGANO and LUCIA trials continue as planned, with no protocol modifications.

According to the company, all patients in both studies have reached the week 8 visit, during which participants in the treatment arms received their initial Duravyu dose, and approximately 25% of those patients have now received their second planned dose at week 32.

DSMC Recommendation Supports Ongoing Safety Profile

“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 Pharmaceuticals.

Dr. Ribeiro added that as the company advances toward topline data, EyePoint remains focused on maintaining trial execution and regulatory preparedness:

“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.”

Phase 3 LUGANO and LUCIA Trials

Enrollment is now complete in both 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 these pivotal phase 3 trials is noninferiority in the average change in best-corrected visual acuity (BCVA) at weeks 52 and 56 compared with baseline.

Secondary endpoints include:

       • Safety outcomes

       • Reduction in treatment burden

       • Percentage of eyes free of supplemental aflibercept injections

       • Anatomical results as measured by optical coherence tomography (OCT)