EyePoint says Phase 3 LUGANO trial of DURAVYU in wet AMD misses primary endpoint
EYPT•Next steps for the DURAVYU program
Topline results from the second pivotal Phase 3 trial, LUCIA, are expected in Q4 2026; an FDA filing is planned for 1H 2027.
LUGANO topline results miss primary vision endpoint
EyePoint reported topline results from LUGANO, a pivotal Phase 3 trial of DURAVYU for wet age-related macular degeneration.
The study missed its primary vision endpoint in the full dataset, weighed down by a small cohort with vision loss unrelated to wet AMD.
Additional analysis showed comparable vision outcomes
An additional analysis excluding that cohort supported comparable vision outcomes versus aflibercept, with lower treatment burden and durable disease control.
Management pointed to a favorable safety profile with repeat dosing, supporting plans to advance the program toward registration.
