Enrollment Complete in Oculis' Phase 2 ACUITY Trial for AON Treatment

Swiss biopharmaceutical firm Oculis has achieved a significant milestone in its Phase 2 clinical trial, the ACUITY study, which focuses on the safety and tolerability of OCS-05 for Acute Optic Neuritis (AON) patients. The multinational trial has completed patient enrollment and is set to release its primary findings by the year's end. This development is particularly noteworthy given that there are currently no approved treatments for AON, a condition characterized by the sudden inflammation of the optic nerve, which can result in permanent vision loss.

The ACUITY trial, which is being conducted at four French medical centers, is a randomized, double-blind, placebo-controlled study. It is designed to assess the effects of a daily intravenous infusion of OCS-05, a serum-glucose corticoid kinase-2 (SGK-2) activator, which holds promise as a neuroprotective therapy. OCS-05 has already been recognized with orphan drug status in both the U.S. and Europe, underscoring its potential to address a significant unmet medical need.

Oculis CEO Riad Sherif, M.D., expressed satisfaction with the trial's progress, highlighting the company's commitment to advancing OCS-05 as a pioneering neuroprotective treatment for various eye diseases, including AON, glaucoma, and diabetic retinopathy. The drug's unique mechanism of action is believed to support neuronal survival and repair by influencing apoptosis, oxidation, and inflammation.

Dr. Sophie Bonnin, a key opinion leader in ophthalmology and scientific advisor for the trial, emphasized the rarity and severity of AON, noting the absence of approved therapies post-acute episodes. She anticipates that OCS-05 could profoundly impact ophthalmology by offering a neuroprotective solution.

Pablo Villoslada M.D., a member of Oculis' Scientific Advisory Board, echoed the enthusiasm for the trial's completion, citing OCS-05's novel mechanism as a potential game-changer in treating ophthalmic diseases requiring neuroprotection.

Oculis is a globally recognized biopharmaceutical company listed on Nasdaq and XICE, with a mission to preserve and enhance vision through innovative treatments. The company's pipeline includes several groundbreaking drug candidates, such as OCS-01 for diabetic macular edema and post-cataract surgery inflammation, and OCS-02 for dry eye disease and uveitis.

The company, headquartered in Switzerland with operations extending to the U.S. and Iceland, is led by a seasoned management team and is backed by prominent international healthcare investors. Oculis is dedicated to improving patient health and quality of life on a global scale.