Clinical TrialJul 30, 2026, 07:07 AM
EyePoint Completes Phase 3 Enrollment for DURAVYU in DME
AI Summary
EyePoint, Inc. announced the completion of enrollment for its two pivotal Phase 3 clinical trials, COMO and CAPRI, evaluating DURAVYU™ for the treatment of diabetic macular edema (DME). Over 480 patients were enrolled across both trials in just five months, ahead of schedule. The company anticipates releasing topline 56-week data for these DME trials in the fourth quarter of 2027. An independent Data Safety Monitoring Committee also recommended the continuation of both DURAVYU's wet AMD and DME Phase 3 programs as planned.
Key Highlights
- EyePoint completed enrollment in two pivotal Phase 3 clinical trials (COMO and CAPRI) for DURAVYU™ in diabetic macular edema (DME).
- Over 480 patients were enrolled across both trials, completing enrollment ahead of schedule in five months.
- Topline 56-week data for both DME trials are anticipated in the fourth quarter of 2027.
- An independent Data Safety Monitoring Committee (DSMC) recommended continuation of both Phase 3 programs (wet AMD and DME) as planned.
- DURAVYU has been evaluated in over 190 patients across four completed clinical trials with a favorable safety profile.
- Phase 3 pivotal data for DURAVYU in wet AMD (LUGANO and LUCIA trials) is anticipated beginning in August 2026.
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