EyePoint Pharmaceuticals announced a positive recommendation from the independent Data Safety Monitoring Committee for their pivotal Phase 3 trials evaluating DURAVYU in wet age-related macular degeneration (AMD).
The trials, LUGANO and LUCIA, are progressing as planned without any protocol modifications based on the safety data review.
DURAVYU's consistent safety profile and trial execution are paving the way for topline data announcement in mid-2026.
DSMC Positive Recommendation
Independent committee supports the continuation of DURAVYU trials without protocol changes, highlighting the favorable safety profile.
Trial Details
LUGANO and LUCIA involve over 900 patients, evaluating DURAVYU's efficacy and safety compared to aflibercept in treating wet AMD.
Treatment Challenge in Wet AMD
Current treatments for wet AMD require frequent injections, posing a burden on patients and healthcare systems, making sustained-delivery options like DURAVYU crucial.
- The positive DSMC recommendation boosts confidence in DURAVYU's potential as a sustained-delivery treatment for wet AMD.
- Progress in the Phase 3 trials signals a significant step towards addressing the treatment burden and improving patient outcomes in wet AMD.
EyePoint's advancement in the DURAVYU trials marks a promising development for the treatment of wet AMD, offering hope for improved patient care and reduced treatment burden in the future.