EyePoint, Inc. filed an 8-K on September 10, 2026, disclosing updated results from the Phase 3 LUGANO clinical trial of its drug candidate DURAVYU. The filing includes an updated investor presentation dated September 10, 2026, which details the trial's findings regarding the treatment of wet age-related macular degeneration (wet AMD).
The LUGANO trial is a randomized, active-controlled study designed to evaluate the efficacy and safety of DURAVYU compared to aflibercept. The trial enrolled 432 patients and utilized a 1:1 randomization to compare DURAVYU 2.7 mg administered every six months against aflibercept 2 mg administered every eight weeks.
The primary endpoint of the study was non-inferiority in mean change in best-corrected visual acuity (BCVA) from Day 1 to Week 52 and Week 56 (blended) compared to the aflibercept control. The filing indicates that DURAVYU did not achieve statistical non-inferiority in the full data set. However, the company notes that non-inferiority was achieved in an analysis excluding an asymmetric cohort, with a nominal p-value of 0.0096.
Despite the primary endpoint not being met in the full dataset, the presentation highlights several positive secondary outcomes. DURAVYU demonstrated a superior reduction in treatment burden compared to aflibercept, with a nominal p-value of less than 0.0001. Additionally, the data showed that 88% of eyes treated with DURAVYU received four injections or fewer over the course of the study. Anatomically, the presentation notes that more than 50% of eyes were controlled by DURAVYU alone with similar central subfield thickness (CST) and BCVA compared to the aflibercept group.
The filing also outlines the company's future expectations. EyePoint anticipates reporting topline results from the Phase 3 LUCIA trial in the fourth quarter of 2026. The company stated its confidence in the DURAVYU program and its belief that it is well-positioned to be the first-to-market among investigational sustained release treatments for wet AMD and diabetic macular edema (DME). EyePoint plans to submit a potential New Drug Application (NDA) to the U.S. Food and Drug Administration for DURAVYU in the first half of 2027.
