Oculis Announces Positive Phase II Results for Licaminlimab (OCS-02) in Severe Dry Eye Disease, Highlighting Potential as First Topical Biologic Therapy

—— Positive Phase II Data Published in Clinical Ophthalmology Highlights the Potential of Licaminlimab as a New Therapy for Dry Eye Disease

—— Successfully achieved primary and secondary efficacy endpoints, demonstrating that licaminlimab is superior to placebo in alleviating ocular discomfort in patients with severe dry eye disease.

—— Licanumab is well-tolerated, with no increase in intraocular pressure or other safety issues observed

Lausanne, Switzerland, August 23, 2022 – Oculis SA ("Oculis"), an international ophthalmology company dedicated to improving vision and protecting eyes through breakthrough technologies and revolutionary therapies, announced that the results of a Phase II clinical trial (NCT02365519) evaluating the efficacy of topical licaminlimab (OCS-02) in relieving overall ocular discomfort in patients with severe dry eye disease, conducted via a double-blind, multicenter, and placebo-controlled study, have been published in the journal Clinical Ophthalmology. The full report is available on the National Institutes of Health (NIH) website.

The study, with the primary efficacy endpoint being the change in total ocular discomfort score from baseline to Day 29, showed results thatStatisticsThe score of OCS-02 (Licaminlimab) (-7.9) was significantly better than that of the vehicle (-3.6) (90% CI -7.7, -0.8; p = 0.041). If the proportion of patients with an improvement of more than 20 points in overall ocular discomfort from baseline to Day 29 is considered one of the primary secondary efficacy endpoints, Licaminlimab (17.9%) was also statistically superior to the vehicle (4.7%) (p = 0.018).

Studies show that licaminlimab (OCS-02) was well tolerated, with no significant difference in safety compared to the vehicle treatment group, and no occurrence of elevated intraocular pressure.

Licaminlimab (OCS-02) is a single-chain antibody (scFv) that can bind to and neutralize the activity of human TNFα, featuring a dual mechanism of action (MoA) with both anti-inflammatory and anti-necrotic properties. Unlike full-length monoclonal antibodies, single-chain antibodies have smaller molecular structures, allowing them to penetrate ocular surface tissues when used as eye drops. This makes it a potential candidate to become the first approved topical biologic for treating dry eye disease.

Dry eye disease is a multifactorial condition where inflammation can rapidly play a central role in maintaining the pathological state. Reports indicate that the global prevalence of dry eye disease is 11.59%, representing approximately 900 million patients worldwide, with the United States alone currently having 16 to 49 million dry eye disease patients. In the U.S., only 9% of diagnosed patients have received treatment, and despite the availability of various options, only 13% of patients achieve lasting relief. The large and growing patient population represents significant unmet medical needs.

Oculis is currently conducting Phase II clinical trials of licaminlimab (OCS-02) for the treatment of dry eye disease and uveitis.

Professor Christophe Baudouin, Professor of Ophthalmology and Chairman of Ophthalmology III at the Quinze-vingts National Ophthalmology Hospital in Paris, stated: "There is currently no drug with a new dual mechanism of action developed to treat inflammation involved in the pathology of dry eye disease. This unmet treatment need indeed exists, and OCS-02 is certainly able to fill this gap. Compared with currently available treatments and other candidate products under research for dry eye disease, OCS-02 has anti-inflammatory and anti-necrotic effects and can play a role in treating the underlying cause. Patients currently have limited treatment options, so I am very much looking forward to the continued development and approval of OCS-02 for the treatment of severe dry eye disease."

Oculis CEO Dr. Riad Sherif stated: "This Phase II data further strengthens our confidence that OCS-02 has the potential to be effective.ManagementNovel Anti-Inflammatory Therapy for Dry Eye Disease, Simultaneously Treating Other Inflammatory Eye Conditions. We plan to initiate a Phase 2b clinical trial of OCS-02 for Dry Eye Disease and Uveitis in the coming months, while we continue advancing OCS-01 for the treatment.DiabetesPhase III clinical trials for macular edema, post-operative inflammation, and pain following ocular surgery. Along with the proof-of-concept (POC) trial of OCS-05 for acute optic neuritis, we are confident that the Oculis ophthalmic drug portfolio can achieve further development to address significant unmet medical needs in key areas of ophthalmology.