Oculis Commences Stage 2 of Phase 3 DIAMOND-1 Trial of OCS-01 Eye Drop in DME

Oculis Holding announced that the 'First Patient First Visit (FPFV)' in stage 2 of its phase 3 DIAMOND-1 trial evaluating OCS-01 for the treatment of DME.

DIAMOND-1 is a phase 3, two-stage, double-masked, randomized, multicenter 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 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. For more information about stage 1 results, click here.

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.

“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," Riad Sherif, MD, Chief Executive Officer of Oculis, said in a company news release. "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.”

“The treatment of DME with repeated intravitreal injections results in a significant burden for our patients. As a field, we have been actively seeking noninvasive alternatives to address DME, aiming to intervene earlier and alleviate treatment burden," said Arshad M. Khanani, MD, MA, 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. "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 ofsStage 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.”