Oculis Announces First Patient Enrolled in Phase 3 OPTIMIZE Trial of OCS-01 in the Treatment of Inflammation and Pain Following Cataract Surgery

Oculis SA announced that the first patient has been enrolled in its phase 3 OPTIMIZE trial evaluating the efficacy and safety of once-daily OCS-01 for the treatment of inflammation and pain following cataract surgery. OCS-01 is a novel, high concentration, preservative-free, topical formulation of dexamethasone that uses the company's Optireach nanoparticle technology.

In the completed phase 2 SKYGGN study, once-daily OCS-01 successfully met its primary endpoint demonstrating superior efficacy and safety vs vehicle (placebo) in the treatment of inflammation and pain following cataract surgery. Positive data from that trial was presented at the American Society of Cataract and Refractive Surgery (ASCRS) 2020 Annual Meeting. Oculis subsequently held a positive end-of-phase 2 meeting with the FDA which enabled the start of the phase 3 OPTIMIZE trial.

OPTIMIZE is a randomized, double-blind, placebo-controlled phase 3 trial in 25 participating sites across the US and is scheduled to enroll approximately 240 patients. Efficacy measures of the trial include the absence of anterior chamber cells at Day 15 and absence of pain at Day 4.

Treatment of inflammation and pain following ocular surgery is another indication being pursued for OCS-01, following the commencement in November 2021 of the phase 3 DIAMOND trial investigating OCS-01 in patients with DME.

“This is another important development milestone for OCS-01, following the start of our Ppase 3 trial in DME last year, which further signals the potential for this novel product candidate to address the limitations of currently available treatments for both retinal and front-of-the-eye indications," Riad Sherif, MD, CEO of Oculis, said in a company news release. "Clinical data generated so far have been very encouraging and we look forward to generating further data in this trial to support regulatory submissions.”

OCS-01 has been developed using Oculis’s Optireach solubilizing nanoparticle technology, a proprietary platform that enables the formulation of drugs as non-invasive topical eyedrop treatments, a longer residence time on the eye surface and enhances their bioavailability in the relevant eye tissues, particularly the retina.