Oculis Completes Enrollment for Phase 2 ACUITY Trial with OCS-05 for Acute Optic Neuritis

Oculis Holding AG, a global biopharmaceutical company dedicated to enhancing eye care and saving sight, has recently announced the completion of patient enrollment for its Phase 2 ACUITY trial. This trial is designed to assess the safety and tolerability of OCS-05 in individuals suffering from Acute Optic Neuritis (AON). The study is being conducted across four sites in France, with topline results expected in the fourth quarter of 2024.

Acute Optic Neuritis is a rare and severe condition involving acute inflammation and demyelination of the optic nerve, often leading to significant vision loss. Currently, there are no approved therapies for this condition, which underscores the critical unmet medical need that OCS-05 aims to address. The drug has already been granted orphan drug designation in both the United States and Europe, highlighting its potential importance in treating this debilitating disease.

The ACUITY trial is a randomized, double-blind, placebo-controlled study that involves once-daily intravenous infusions of OCS-05. The primary goal is to evaluate the drug's safety and tolerability. The study's completion marks a significant milestone in the clinical development of OCS-05 and keeps the company on track for its anticipated topline readout.

Riad Sherif, M.D., CEO of Oculis, commented on this milestone, stating, "We are pleased to have completed enrollment in the ACUITY trial, an important step forward for our OCS-05 clinical program. We are also working towards submitting an Investigational New Drug (IND) application for OCS-05 in the United States in 2024. The anticipated positive outcomes from this trial could pave the way for OCS-05 to become a first-in-class neuroprotective treatment with broad applications in neuro-ophthalmic diseases, such as AON, glaucoma, geographic atrophy, and diabetic retinopathy."

Dr. Sophie Bonnin, Deputy Head of the Ophthalmology Department at Rothschild Foundation Hospital in Paris and Scientific Advisor for the ACUITY trial, emphasized the unmet needs in treating AON. "While corticosteroids are used to manage acute attacks, there are no approved therapies that can prevent vision loss after an episode of optic neuritis. The completion of enrollment in this trial brings us closer to developing OCS-05 as a potential neuroprotective treatment that could have a significant impact on ophthalmology."

Dr. Pablo Villoslada, Chair of the Department of Neurology at Hospital del Mar in Barcelona and member of Oculis' Scientific Advisory Board, highlighted the innovative mechanism of action of OCS-05. "The drug's ability to trigger multiple beneficial effects on apoptosis, oxidation, and inflammation supports neuronal survival and repair. The results from this Phase 2 trial will provide valuable insights into its clinical efficacy and potential benefits for patients with neuro-ophthalmic diseases."

OCS-05 is an investigational drug that acts as a serum-glucose corticoid kinase-2 (SGK-2) activator, offering potential neuroprotective benefits. In animal models, the drug has shown promise in preventing retinal ganglion cell damage and improving clinical function. The Phase 2 ACUITY study aims to validate these findings in human subjects, potentially leading to new treatment options for conditions that involve neuroprotection.

Oculis is headquartered in Switzerland, with operations in the U.S. and Iceland, and is committed to advancing a pipeline of innovative product candidates. Their portfolio includes OCS-01 for diabetic macular edema and post-cataract surgery inflammation, OCS-02 for dry eye disease and non-infectious anterior uveitis, and OCS-05 for AON. The company's mission is to improve the health and quality of life for patients worldwide, guided by a seasoned management team and supported by leading international healthcare investors.