Core Insights - EyePoint Pharmaceuticals has successfully completed enrollment for its Phase 3 pivotal trials, LUGANO and LUCIA, for the treatment of wet age-related macular degeneration (wet AMD) with over 800 patients enrolled across both trials, marking one of the fastest enrollment rates in this indication [1][4][5] - The independent Data Safety Monitoring Committee (DSMC) has confirmed the safety profile of DURAVYU is consistent with previous trials, recommending the continuation of the program as planned [2][3] - Topline data for the LUGANO trial is expected in mid-2026, with LUCIA data to follow closely [1][3] Enrollment and Trial Design - The LUCIA trial enrolled and randomized over 400 patients in just seven months, demonstrating strong enthusiasm from the retinal community for the DURAVYU program [1][4] - Both LUGANO and LUCIA trials are randomized, double-masked, aflibercept-controlled, non-inferiority Phase 3 trials assessing DURAVYU's efficacy and safety in active wet AMD patients [5] - The trials are designed to evaluate a 6-month redosing schedule, which could significantly reduce the treatment burden for patients [5][6] Safety and Efficacy - DURAVYU has shown a favorable safety and tolerability profile across over 190 patients in previous clinical trials, with no serious adverse events related to the drug reported [2][8] - The Phase 2 DAVIO 2 trial provided robust safety and efficacy data that supports the ongoing Phase 3 program [3][9] - DURAVYU demonstrated an impressive treatment burden reduction of approximately 88% six months after treatment, with over 80% of patients being supplement-free or requiring only one supplemental anti-VEGF injection [8] Regulatory and Market Potential - The Phase 3 pivotal program has been developed in alignment with the FDA and EMA, following recognized industry best practices to enhance regulatory and commercial success [3][12] - EyePoint aims to bring the first sustained-release TKI for wet AMD to market, addressing a significant unmet need in the treatment landscape [4][12] - The company is also evaluating DURAVYU for diabetic macular edema (DME), with positive Phase 2 results supporting advancement to a Phase 3 pivotal program [10][11]