Oculis Holding AG announced on April 10, 2025, the successful completion of enrollment in both its Phase 3 DIAMOND-1 and DIAMOND-2 trials for OCS-01 eye drops in diabetic macular edema (DME). These trials are designed as pivotal registration studies to support global marketing applications, including submission for approval by the U.S. Food and Drug Administration (FDA).
The company enrolled over 800 patients across 119 investigative sites in the United States and several other countries. This rapid completion of enrollment for the DIAMOND program is a critical milestone, advancing OCS-01 towards becoming the first topical eye drop treatment for DME.
Topline data from both Phase 3 trials is expected in the second quarter of 2026, with an NDA submission to follow thereafter. The successful enrollment underscores the recognition among investigators and patients of OCS-01's potential as an effective, non-invasive therapy for DME, addressing a significant unmet medical need.
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