Oculis completes enrollment in Phase 3 OCS-01 OPTIMIZE trial

OCS-01 is also being evaluated in another ongoing Phase 3 clinical trial, the DIAMOND study, as potentially the first topical treatment for diabetic macular edema (DME), if approved. (Image Credit: Adobe Stock/angellodeco)

Oculis Holding AG today announces the completion of enrollment for its Phase 3 OPTIMIZE trial evaluating the efficacy and safety of once-daily OCS-01, a novel, high-concentration, preservative-free, topical OPTIREACH formulation of dexamethasone for the treatment of inflammation and pain following cataract surgery.

According to a news release, the OPTIMIZE trial is a randomized, double-blind, placebo-controlled Phase 3 trial in 25 participating sites across the US, with 240 patients. Efficacy measures include the absence of inflammation at Day 15 and the absence of pain at Day 4.

In the completed Phase 2 SKYGGN study, OCS-01 met its primary and secondary endpoints of the absence of anterior chamber cells and absence of pain, achieving statistical significance for patients who received once-daily dosing of OCS-01 vs vehicle in the treatment of inflammation and pain following cataract surgery. OCS-01 was also well tolerated in this trial. These data were presented at the American Society of Cataract and Refractive Surgery (ASCRS) 2020 Annual Meeting and published in Clinical Therapeutics.¹

The company noted the results from the SKYGGN Phase 2 trial showed OCS-01, administered once daily or twice daily, was more effective than vehicle with respect to the primary and secondary endpoints and well-tolerated in the treatment of inflammation and pain following cataract surgery.

In its news release, the company also noted the once-a-day data from the trial demonstrated that OCS-01’s unique formulation may allow for effective and safe once-a-day dosing. Once-daily administration of OCS-01 is expected to facilitate compliance, minimize instillation challenges, and eliminate confusion caused by complicated tapering schedules. In addition, reduced frequency of medication coupled with preservative-free preparations can improve the health of the ocular surface.

Riad Sherif, MD, CEO of Oculis, lauded the efforts of everyone involved in the Phase 3 clinical trial.

“I would like also to thank all our partners and investigators for their great commitment to clinical development,” he said in the news release. “I am proud of the rapid progress we are making towards our goal of delivering life-changing innovative treatments to patients."

Eric Donnenfeld, MD, of Ophthalmic Consultants of Long Island, noted OCS-01 could prove to be an effective treatment option

"OCS-01 could bring significant therapeutic benefit as a once-daily treatment for inflammation and pain following ocular surgery. In addition, given its ability to reach the back of the eye, it could also offer further benefit in treating retinal edema, as shown in Oculis’ DME Phase 2 trial and previous exploratory trial in CME, a significant complication following ocular surgery."

OCS-01 is also being evaluated in another ongoing Phase 3 clinical trial, the DIAMOND study, as potentially the first topical treatment for diabetic macular edema (DME), if approved. It has been developed using Oculis’ OPTIREACH technology, a proprietary platform that enables the formulation of drug candidates as topical eye drops with longer residence time on the eye surface, and enhanced bioavailability in the relevant eye tissues, including the retina.

Reference:

1. Korenfeld M, Gira J, Jong K, Martel J, Vold S, Walters T, Usner D, Donnenfeld E. OCS-01 (Novel Topical Dexamethasone Formulation) in Inflammation and Pain Post Cataract Surgery: A Randomized, Double-Masked, Vehicle-Controlled Study. Clin Ther. 2022 Dec;44(12):1577-1587. doi: 10.1016/j.clinthera.2022.11.003. Epub 2022 Dec 8. PMID: 36503736.