EyePoint LUGANO Phase 3 Trial Misses Primary Endpoint For Duravyu In Wet AMD

(RTTNews) - EyePoint, Inc. (EYPT), a clinical-stage biopharmaceutical company, on Monday reported topline results from the Phase 3 LUGANO trial, evaluating Duravyu, an investigational sustained-delivery treatment for wet age-related macular degeneration (wet AMD).

The trial did not achieve its primary endpoint of change from baseline in best corrected visual acuity (BCVA) versus the 2 mg aflibercept control in the full dataset.

EyePoint said the primary result was confounded by a 4% asymmetric cohort of patients who experienced vision loss of 15 letters or more unrelated to wet AMD. No patients in the aflibercept control arm experienced non-wet AMD-related vision loss.

Excluding this cohort, Duravyu was non-inferior to the on-label aflibercept control, according to the company.

Topline data from LUCIA, the second pivotal Phase 3 clinical trial evaluating Duravyu in wet AMD, are expected in the fourth quarter of 2026, with a potential FDA New Drug Application submission planned for the first half of 2027.

EyePoint shares were up nearly 4% in pre-market trading after closing at $14.75 on Friday.