Oculis: Phase 3 trial of eye drops in Diabetic Macular Edema

Oculis Holding AG (Nasdaq: OCS) (“Oculis”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, announces 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.

Riad Sherif, M.D., Chief Executive Officer of Oculis, remarked: “2023 has been a remarkable year for us with the achievement of multiple key milestones and timely execution of our development plans. A few weeks ago, we announced the initiation of the RELIEF Phase 2b Trial with OCS-02 in Dry Eye Disease and have now reached another key development milestone with the initiation of the Stage 2 of the Phase 3 DIAMOND-1 trial with OCS-01 in DME. OCS-01 is a promising clinical candidate that has already demonstrated its potential to treat both front and back of the eye indications with the positive results from Stage 1 of the DIAMOND trial in DME and the Phase 3 OPTIMIZE trial in inflammation and pain following cataract surgery. If approved, OCS-01 could become the first eye drop for DME and potentially transform the current treatment paradigm.”

Arshad M. Khanani, M.D., M.A., FASRS, Co-Principal Investigator for the DIAMOND trial; Oculis Scientific Advisory Board member; Director of Clinical Research at Sierra Eye Associates and Clinical Associate Professor at University of Nevada, Reno School of Medicine, commented: “The treatment of DME with repeated intravitreal injections results in a significant burden for our patients. As a field, we have been actively seeking non-invasive alternatives to address DME, aiming to intervene earlier and alleviate treatment burden. OCS-01 eye drops have emerged as a potential solution for this unmet need, and the encouraging results from Stage 1 of the DIAMOND-1 Phase 3 trial support this outlook. The initiation of Stage 2 of the DIAMOND-1 study marks a crucial advancement in the development of OCS-01, positioning it as a promising non-invasive treatment option for patients with DME.”