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– Over 400 patients enrolled and randomized over a seven-month period, driven by strong physician and patient interest –
– LUCIA pivotal Phase 3 trial continues rapid enrollment pace with 60% of patients randomized; enrollment completion expected in 3Q 2025 –
– Topline 56-week data for LUGANO expected in mid-2026 with LUCIA to follow –
WATERTOWN, Mass., May 27, 2025 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced it has enrolled and randomized over 400 patients in the Phase 3 LUGANO pivotal trial of DURAVYU™ for the treatment of wet age-related macular degeneration (wet AMD) exceeding its enrollment target. The seven-month enrollment for LUGANO represents one of the fastest enrolling Phase 3 pivotal trials for wet AMD to date.
LUGANO is the first of two pivotal non-inferiority trials underway in the Phase 3 program of DURAVYU for the treatment of wet AMD. Supported by the robust DAVIO 2 Phase 2 clinical trial in over 160 patients, the Phase 3 pivotal program was developed in direct alignment with the U.S. Food and Drug Administration (FDA), follows recognized industry best practices, and is strategically designed to enhance the potential for regulatory and commercial success. All patients are randomized on Day 1 and immediately begin treatment with a one-year efficacy and safety endpoint. With the completion of enrollment for LUGANO, topline data is anticipated in mid-2026.
Posted In: EYPT
