Oculis Holding AG announced First Patient First Visit (FPFV) in Stage 2 of its Phase 3 DIAMOND-1 trial evaluating Oculis? lead product candidate OCS-01 for the treatment of DME, a leading cause of preventable blindness in working-age adults affecting approximately 37 million people worldwide.
DIAMOND-1 (DIAbetic Macular edema patients ON a Drop) is a Phase 3, two-stage, double-masked, randomized, multi-center trial to assess the efficacy and safety of OCS-01 eye drops in DME patients. The primary objective of the 3-month Stage 1 was to select the optimal dosing regimen (n=148). OCS-01 achieved the primary endpoint with robust statistical significance showing improvement in Best Corrected Visual Acuity (BCVA) vs. vehicle at Week 6 following the induction phase (OCS-01: 7.2 letters vs. vehicle: 3.1 letters, p=0.007). The effect was sustained to Week 12 with the maintenance dose. Furthermore, 27.4% of patients in the OCS-01 group achieved =15-letter improvement in BCVA from baseline vs. 7.5% in the vehicle group at Week 12 (p=0.009). A statistically significant decrease in Central Subfield Thickness (CST) was also observed. In Stage 1, OCS-01 was well-tolerated with no unexpected adverse events observed. Stage 2 of the trial aims to enroll 350-400 patients who will be randomized 1:1 to receive OCS-01 or vehicle six times daily for a 6-week induction phase and then three times daily for a subsequent 46-week maintenance phase. The endpoints for Stage 2 will be the same as in Stage 1 and evaluated at Week 52.