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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 completed enrollment of its Phase 3 pivotal program with the full enrollment of the LUCIA trial, the second of two identical ongoing pivotal non-inferiority trials evaluating DURAVYU™ for the treatment of wet age-related macular degeneration (wet AMD). The first pivotal trial, LUGANO, completed enrollment in May 2025. The LUCIA trial has enrolled and randomized over 400 patients in seven months making DURAVYU one of the fastest enrolling Phase 3 pivotal programs in wet AMD.
The Company also announced that based on interim masked safety data, the safety profile observed in LUGANO and LUCIA is consistent with previous DURAVYU clinical trials. DURAVYU has been evaluated in over 190 patients across four clinical trials demonstrating a favorable safety and tolerability profile including no DURAVYU related ocular or systemic serious adverse events observed. In parallel, an independent Data Safety Monitoring Committee ("DSMC") convened and recommended continuation of the program as planned.
LUGANO and LUCIA are supported by the robust safety and efficacy data from the DAVIO 2 Phase 2 clinical trial. The Phase 3 pivotal program was developed in alignment with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), follows recognized industry best practices, and is strategically designed to enhance the potential for regulatory and commercial success. All patients are randomized on Day One and immediately begin treatment with a one-year efficacy and safety endpoint to support an NDA filing. With the completion of enrollment for LUCIA, topline data is anticipated to follow shortly after topline data for LUGANO which is expected in mid-2026.
Posted In: EYPT
