Oculis Holding AG (OCS) said Thursday its Phase 3 DIAMOND-1 and DIAMOND-2 trials evaluating OCS-01 eye drops in patients with diabetic macular edema, a condition caused by fluid buildup in the retina due to diabetes, failed to meet primary endpoint of mean change in best corrected visual acuity, or BCVA.

The drug did not demonstrate a statistically significant improvement in vision scores compared to vehicle, an inactive comparator, across both trial, the company said.

The key secondary endpoint of the proportion of patients achieving a 15-letter or greater gain in BCVA was also not met in both trials.

The drug was well tolerated with no unexpected adverse events, and the safety profile was consistent with previous trials, the company said.

Based on the results, Oculis does not plan to pursue an FDA regulatory filing for OCS-01 in diabetic macular edema at this time, and will redirect resources toward its two other registrational programs in optic neuropathies and dry eye disease.

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