Oculis announces first patient enrolled in Phase 3 OPTIMIZE trial

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OCS-01 is being reviewed for the treatment of inflammation and pain after cataract surgery, with the potential to become the first once-daily, topical and preservative-free corticosteroid for treating inflammation and pain following ocular surgery.

Oculis S.A. this week announced that the first patient has been enrolled in its Phase 3 OPTIMIZE (Once-daily Post ocular surgery Treatment for InflaMmation and paIn to minimiZE drops) 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 the company, in the completed Phase 2 SKYGGN study, once-daily OCS-01successfully met its primary endpoint demonstrating superior efficacy and safety vs vehicle (placebo) in the treatment of inflammation and pain following cataract surgery.

The company also noted that it subsequently held a positive end-of-Phase 2 meeting with U.S. FDA, which enabled the start of the Phase 3 OPTIMIZE trial.

OPTIMIZE is a randomly assigned, 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.

Eric Donnenefeld, MD, clinical professor of ophthalmology at New York University and Trustee of Dartmouth Medical School, discussed the need for an effective option to treat inflammation after cataract surgery.

“Following cataract surgery, patients often need to self-administer eye drops several times a day to manage inflammation and pain,” he said in a statement. “An efficacious, preservative-free alternative, administered just once a day could provide significant advantages over current options.”

Moreover, Riad Sherif, MD, CEO of Oculis, pointed out that the start of the Phage 3 trial marks a key development milestone for OCS-01, following the start of the company’s Phase 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.

“Clinical data generated so far have been very encouraging and we look forward to generating further data in this trial to support regulatory submissions,” Sherif said.

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.