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 regulatory filing for OCS-01 in DME.
The DIAMOND program (DIAbetic Macular edema patients ON a Drop) consisted of two Phase 3, double-masked, randomized, multi-center trials conducted over 52 weeks. More than 800 patients were enrolled across 119 investigational sites in the United States and several other countries.
In terms of safety, OCS-01 was well tolerated, with no unexpected adverse events reported. The overall safety profile was consistent with earlier studies, confirming its favorable tolerability.
OCS closed at $22.71 on May 29 at 4:00 PM EDT, reflecting a decline of $6.94 or 23.42%. In after-hours trading later that evening, at 7:59 PM EDT, the stock dropped further to $15.01, down $7.70 or 33.89%.
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