EyePoint announces LUCIA Phase 3 topline data: primary endpoint missed, secondary endpoints met
EyePoint reported topline data from the LUCIA Phase 3 trial of DURAVYU in wet AMD, which did not achieve the primary endpoint of non-inferiority in mean change in BCVA versus on-label aflibercept (DURAVYU +2.5 letters vs. aflibercept +6.1 letters; difference -3.7 letters). Key secondary endpoints were met, including a 38% reduction in treatment burden (nominal p<0.0001), 52% supplement-free rate and 71% zero-or-one supplement rate through Week 56, with continued favorable safety. LUGANO, the first pivotal Phase...
Key takeaways
Both pivotal Phase 3 trials of DURAVYU in wet AMD (LUGANO and LUCIA) missed their primary endpoints of non-inferiority in mean change in BCVA versus on-label aflibercept.
LUCIA primary endpoint detail: DURAVYU +2.5 letters vs. aflibercept +6.1 letters at blended Weeks 52/56, a -3.7-letter difference outside the 4.5-letter non-inferiority margin.
Secondary treatment-burden endpoints were met across both trials: 38% reduction in LUCIA, 42% in LUGANO, and 40% in the pooled dataset (nominal p<0.0001).
In LUCIA, 52% of DURAVYU eyes were supplement-free and 71% received zero or one supplement through Week 56.
Safety profile remained favorable with redosing; no cases of insert migration, anterior chamber opacities, free-floating particles, or retinal vasculitis reported.
DME Phase 3 program (COMO and CAPRI) remains on track, with topline data from both trials anticipated in Q4 2027.
EyePoint stated it will conduct additional analyses of the LUCIA and pooled Phase 3 datasets to assess next steps for DURAVYU in wet AMD.
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