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Oculis Shelves FDA Filing After Phase 3 DME Trials Miss Key Vision Goals

IS FDA OCS Diamond Nasdaq MarketBeat

Oculis (NASDAQ:OCS) said its two Phase 3 DIAMOND trials of OCS-01 in diabetic macular edema did not meet their primary endpoints, and the company does not currently plan to pursue a U.S. Food and Drug Administration filing for the drug candidate in that indication.

Chief Executive Officer Riad Sherif said on the company’s conference call that Oculis was “naturally disappointed” with the outcome of the DIAMOND-1 and DIAMOND-2 studies. Both trials evaluated OCS-01 against vehicle in patients with diabetic macular edema, or DME, with the primary endpoint measured by change in best-corrected visual acuity, or BCVA, at week 52.

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