Oculis Announces Completion of Enrollment in Phase 2 Randomized Controlled ACUITY Trial with OCS-05 for Acute Optic Neuritis

• Topline results anticipated in Q4 2024 for Phase 2 trial evaluating the safety and tolerability of OCS-05 in patients with Acute Optic Neuritis (AON)
  
• Oculis also aims to complete an IND submission for OCS-05 in the U.S. in 2024
• OCS-05 has been granted orphan drug designation in the United States and Europe for AON, an indication for which there are no approved therapies
  

ZUG, Switzerland, May 08, 2024 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS; XICE: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced the completion of enrollment in its multi-center, randomized, double-blind, placebo-controlled Phase 2 ACUITY trial evaluating the safety and tolerability of OCS-05 in patients with Acute Optic Neuritis (AON). Topline results are expected in Q4 2024.

The Phase 2 ACUITY study is evaluating once-daily OCS-05 intravenous infusion in patients with AON. The study is ongoing across four (4) sites in France.

At present, there are no approved therapies for AON, leaving a significant gap in medical care for treatments that offer neuroprotection and can prevent vision loss. OCS-05 has been granted orphan drug designation in both the United States and Europe, highlighting the importance of this unmet medical need.

Riad Sherif, M.D., Chief Executive Officer of Oculis, commented: “We continue to execute on our strategic programs and are pleased to complete enrollment in the ACUITY trial, an important milestone for OCS-05 clinical program that keeps us on track for an anticipated topline readout in Q4 this year. In the meantime, we keep on working towards an IND submission for OCS-05 in the U.S. in 2024. We anticipate that a positive readout in this trial would support further development of OCS-05 as a potential first-in-class neuroprotective treatment with wide applicability in neuro-ophthalmic diseases such as AON, glaucoma, geographic atrophy, diabetic retinopathy and other diseases where protecting retinal neurons is key to preserving patients’ sight.”

Sophie Bonnin M.D., Ph.D., Deputy Head of the Ophthalmology Department, at Rothschild Foundation Hospital, in Paris, and Scientific Advisor for the ACUITY trial, said: “AON is a rare disease characterized by acute inflammation and demyelination of the optic nerve. While corticosteroids are used to shorten the attack, there is no approved therapy for AON and unmet needs remain for therapies that can prevent vision loss after an acute episode of optic neuritis. The completed enrollment brings us a step forward in the development of OCS-05 as a potential neuroprotective candidate which could have a profound impact in ophthalmology, and we are eagerly awaiting the anticipated trial readout in Q4 of this year.”