EyePoint's DURAVYU Phase 3 LUGANO trial for wet AMD missed its primary endpoint due to an asymmetric cohort experiencing unrelated vision loss. However, the drug demonstrated strong performance in key secondary endpoints, including significant reduction in treatment burden and high supplement-free rates, suggesting potential for a meaningful improvement in wet AMD treatment.
EyePoint announced topline results from its LUGANO Phase 3 trial for DURAVYU in wet AMD. While the primary endpoint of change from baseline in best corrected visual acuity (BCVA) was not met in the full dataset, this was attributed to an 'asymmetric cohort' of patients experiencing vision loss unrelated to wet AMD. Crucially, an ad hoc analysis excluding this cohort showed non-inferiority to the control, and key secondary endpoints, such as a 42% reduction in treatment burden and high supplement-free rates, were highly positive. This creates a mixed signal for traders: the primary endpoint miss is a short-term negative, but the strong secondary data and the explanation for the primary miss offer long-term opportunity if the FDA considers the full context. The next catalyst is the LUCIA trial results in Q4 2026, with an FDA submission planned for 1H 2027.