OCS-01 Phase 3 DIAMOND trials miss primary vision endpoint, prompting no FDA filing

 

• Oculis announced May 29, 2026 that both DIAMOND-1 and DIAMOND-2 Phase 3 trials of OCS-01 eye drops in DME failed primary BCVA change from baseline at week 52.
• Key secondary endpoint (proportion with ≥15-letter BCVA gain) also missed in both trials despite substantial retinal thickness reduction vs vehicle.
• OCS-01 was well-tolerated with safety consistent with prior studies; no unexpected adverse events.
• Company stated it will not pursue FDA regulatory filing for OCS-01 in DME and is redirecting resources to Privosegtor (optic neuropathies PIONEER program) and Licaminlimab (dry eye PREDICT-1).
• CEO Riad Sherif: "disappointed that the substantial and sustained reduction in retinal thickness... didn’t translate into BCVA improvement at week 52."
• $278M cash provides runway into 2H 2029, supporting continued late-stage pipeline execution.
• Stock fell ~23% on May 29 (close ~$22.71 from $29.65) with further extended-hours decline reaching ~34% drop, matching the reported premarket move.

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