other material
confidence high
sentiment negative
materiality 0.87
EyePoint's LUCIA Phase 3 DURAVYU trial misses primary BCVA non-inferiority endpoint in wet AMD
EyePoint, Inc.
- LUCIA (475 patients) failed the primary endpoint of statistical non-inferiority in mean BCVA change vs on-label 2 mg aflibercept, despite demonstrating visual improvement.
- Key secondary endpoints met: 38% reduction in treatment burden (nominal p<0.0001), 52% of eyes supplement-free and 71% receiving zero or one supplement through Week 56.
- Favorable safety profile with redosing and strong anatomic control at Week 56, consistent with LUGANO (432 patients), which also missed its primary endpoint.
- EyePoint will complete additional analyses of LUCIA and pooled Phase 3 datasets to assess next steps for DURAVYU in wet AMD.
- DME program on track: pivotal COMO and CAPRI topline data expected Q4 2027; Phase 2 VERONA showed +7.1 letter BCVA gain and 73% supplement-free at Week 24.
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