Oculis AG, has completed the enrollment for its Phase 3 OPTIMIZE trial evaluating the efficacy and safety of once-daily OCS-01, a novel, high concentration, preservative-free, corticosteroid for treating inflammation and pain following cataract surgery. The trial brings OCS-01 an important step further on the regulatory path to approval.
Headquartered in Switzerland and with operations in the US, Europe, and China, Oculis is a global biopharmaceutical company dedicated to saving sight and improving eye care. Its pipeline comprises multiple innovative product candidates, including OCS-01, a topical retinal candidate for diabetic macular edema (DME).
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.
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. 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.
Based on the positive results, Oculis is progressing into the phase 3 OPTIMIZE trial. The OPTIMIZE (Once-daily Post ocular surgery Treatment for InflaMmation and paIn to minimiZE drops) 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.
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.
(Press release/RAN)
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