– DURAVYU was non-inferior to on-label aflibercept control (nominal p-value = 0.0096) in an ad hoc analysis excluding a 4% asymmetric cohort (9 of 211 patients) who experienced vision loss (≥ 15 letters) unrelated to wet AMD; primary endpoint not achieved in full dataset, confounded by this asymmetric cohort –

– LUGANO demonstrated clinically meaningful results that reinforce DURAVYU’s potential to improve the treatment paradigm in wet AMD, with compelling key secondary endpoints, including reduction in treatment burden, supplement-free rates, favorable safety profile with redosing, and strong anatomic control through Week 56 compared to on-label aflibercept –

– 42% reduction in treatment burden achieving superiority versus on-label aflibercept

(nominal p-value of <0.0001) –

– 76% of DURAVYU patients were supplement-free up to Week 32 –

– 54% of DURAVYU patients were supplement-free and 79% received 0 or 1 supplement up to Week 56; pre-specified analysis on change in BCVA in the supplement-free DURAVYU patients showed non-inferiority to supplement-free aflibercept (nominal p-value = 0.0035) –

– Topline data from LUCIA, the second pivotal Phase 3 clinical trial in wet AMD, expected in Q4 2026 with potential FDA New Drug Application submission planned for 1H 2027 –

– Conference call to discuss the results to be held today at 8:00 a.m. EDT –
 

WATERTOWN, Mass., Aug. 17, 2026 (GLOBE NEWSWIRE) -- EyePoint, Inc. (NASDAQ:EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced topline results from LUGANO, the first pivotal Phase 3 clinical trial for DURAVYU™ (vorolanib intravitreal insert) for the treatment of wet age-related macular degeneration (wet AMD).

DURAVYU was non-inferior to on-label aflibercept (nominal p-value = 0.0096) in an ad hoc analysis excluding a 4% asymmetric cohort (9 of 211 patients) who experienced vision loss (≥ 15 letters) unrelated to wet AMD. Despite the outperformance in key secondary endpoints, the primary endpoint of change from baseline in best corrected visual acuity (BCVA) versus 2 mg aflibercept on-label control was not achieved in the full dataset, confounded by this asymmetric cohort. In contrast, no patients experienced vision loss (≥ 15 letters) unrelated to wet AMD in the aflibercept control arm. In prior reported similar scale pivotal Phase 3 trials, approximately 3-5% of aflibercept patients lost ≥15 letters1, indicating meaningful overperformance of the on-label aflibercept control group in LUGANO that also contributed to the primary endpoint performance.

LUGANO demonstrated clinically meaningful results that reinforce DURAVYU’s potential to improve the treatment paradigm in wet AMD, with compelling key secondary endpoints in reduction in treatment burden, supplement-free rates, a favorable safety profile with redosing, and anatomic control through Week 56 compared to on-label aflibercept. These results represent a meaningful improvement to current wet AMD standard of care.