Clinical TrialMay 29, 2026, 02:54 PM
Oculis OCS-01 Phase 3 DME trials fail primary endpoint
AI Summary
Oculis Holding AG announced that its Phase 3 DIAMOND-1 and DIAMOND-2 trials for OCS-01 eye drops in diabetic macular edema (DME) did not meet the primary endpoint of mean change in best corrected visual acuity (BCVA) at Week 52. While a secondary endpoint showed substantial reduction in retinal thickness, the company will not pursue an FDA regulatory filing for OCS-01 in DME. Oculis plans to reallocate resources to its Privosegtor PIONEER program for optic neuropathies and Licaminlimab PREDICT-1 trial for dry eye disease, supported by a strong financial position with $278 million in cash and a runway into 2H 2029.
Key Highlights
- Oculis's OCS-01 Phase 3 DIAMOND-1 and DIAMOND-2 trials for DME failed to meet the primary endpoint of mean change in BCVA at Week 52.
- Secondary endpoint of retinal thickness showed substantial and persistent reduction with OCS-01 vs vehicle in both trials.
- Oculis does not plan to pursue an FDA regulatory filing for OCS-01 in DME based on these results.
- Company will focus resources on Privosegtor PIONEER program (optic neuropathies) and Licaminlimab PREDICT-1 trial (dry eye disease).
- Oculis reported $278 million in cash, cash equivalents, and short-term investments as of March 31, 2026.
- Cash runway is projected into 2H 2029.
- Over 800 patients were enrolled across 119 investigational sites for the DIAMOND program.
Price Impact
More from OCS