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Oculis Completes Enrollment in Phase 3 OCS-01 OPTIMIZE Trial
Completed enrollment in Phase 3 OPTIMIZE trial brings OCS-01 one step further on the regulatory path to approval.If approved, OCS-01 has the potential to
About this update from Oculis Holding Ag
[{"type":"text","content":"Completed enrollment in Phase 3 OPTIMIZE trial brings OCS-01 one step further on the regulatory path to approval.If approved, OCS-01 has the potential to become the first once-daily, topical, preservative-free corticosteroid for treating inflammation and pain following ocular surgery.Significant progress made with OCS-01 (Oculis’ lead clinical candidate) - additional results expected later this year from stage one of the Phase 3 DIAMOND trial in Diabetic Macular Edema (DME). LAUSANNE, Switzerland, March 16, 2023 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis”) a global biopharmaceutical company purposefully driven to save sight and improve eye care, 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. 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 absence of pain at Day 4. In the completed Phase 2 SKYGGN study, OCS-01 met its primary and secondary endpoints of 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. The study, “OCS-01 in Treating Inflammation and Pain in Post-cataract Patients (SKYGGN)”, is accessible on the National Institutes of Health (NIH) website here. 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...