India, May 30 -- Oculis Holding AG (OCS) announced that its Phase 3 DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops in patients with diabetic macular edema (DME) did not achieve the primary endpoint. The mean change in best corrected visual acuity (BCVA) measured by ETDRS letter score at Week 52 was not met in either study. The key secondary endpoint - the proportion of patients with a greater than or equal to 15-letter gain in BCVA - was also not met.However, reductions in retinal thickness, measured by OCT, were substantial and persistent with OCS-01 compared to vehicle, observed at all visits in DIAMOND-2 and at all visits except Week 52 in DIAMOND-1.
Based on these findings, Oculis has stated that it does not plan to pursue an FDA r...