New Data for Bioerodible DURAVYU in Wet AMD
Tarek S. Hassan provides perspective on the Phase 3 LUGANO topline results and the path forward for DURAVYU in wet age-related macular degeneration (AMD)
Objective: To evaluate the efficacy and safety of DURAVYU (EYP-1901) in comparison to aflibercept in patients with wet AMD.
Approach: Trial Design: The LUGANO trial was a randomized, double-masked Phase 3 study comparing DURAVYU 2.7 mg to aflibercept 2 mg every 8 weeks.Primary Endpoint: The primary endpoint was the mean change in best-corrected visual acuity (BCVA), which was not met in the full dataset.Secondary Endpoints: Key secondary endpoints showed strong anatomic control, durability, and reduced treatment burden.Key Findings: Mean vision improved in the full DURAVYU cohort despite not meeting the primary endpoint. Nine patients in the DURAVYU group experienced ≥15-letter vision loss from causes not related to neovascular AMD. DURAVYU demonstrated a 42% reduction in treatment burden compared to aflibercept. 76% of DURAVYU-treated patients remained supplement-free at Week 32. Interpretation: The unexpected imbalance in vision loss among a small subset of patients affected the primary endpoint results.
Limitations: The primary endpoint was not met in the full analysis set. The results were influenced by an imbalance in vision loss cases. Conclusion: The results of the LUGANO trial indicate the need for further validation in the upcoming LUCIA trial.
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