EYPT · EyePoint Pharmaceuticals, Inc.

EyePoint's announcement of the third consecutive positive recommendation from the independent Data Safety Monitoring Committee (DSMC) for its pivotal Phase 3 LUGANO and LUCIA trials represents a significant de-risking milestone for DURAVYU in wet AMD. The DSMC, comprising ophthalmology and biostatistics experts, reviewed unmasked safety data and confirmed no need for protocol changes, aligning with the favorable safety observed across four prior clinical trials involving over 190 patients. This consistency underscores the reliability of DURAVYU's profile as it advances toward topline results, with LUGANO data expected mid-2026 and LUCIA following. Trial progress is robust: enrollment of over 900 patients is complete, all active treatment arm participants have received their second 2.7mg dose at Week 32, and more than 35% have progressed to the third dose at Week 56. As the only Phase 3 program testing 6-month redosing in sustained release wet AMD therapies over two years, DURAVYU's non-inferiority design against aflibercept on BCVA change at Weeks 52 and 56, plus secondary endpoints like treatment burden reduction, positions it for potential paradigm shift in managing this lifelong disease. Chief Medical Officer Ramiro Ribeiro emphasized safety's paramount role and growing confidence ahead of data readouts. Investors should note this is the final scheduled DSMC review before topline results, reducing near-term safety uncertainties while topline efficacy remains pending.