Oculis Reports Positive Phase 2b RELIEF Trial Results for Licaminlimab in Dry Eye Disease

ZUG, Switzerland, June 10, 2024 - Oculis Holding AG (Nasdaq: OCS), a global biopharmaceutical company, has revealed encouraging topline results from its Phase 2b RELIEF trial involving licaminlimab, a cutting-edge anti-TNFα biologic eye drop. The trial demonstrated the efficacy and safety of licaminlimab in treating dry eye disease (DED), focusing particularly on patients with a TNFR1 genetic biomarker, which indicated stronger treatment effects.

The Phase 2b RELIEF trial was a multi-center, randomized, double-masked, vehicle-controlled study that evaluated the impact of licaminlimab on DED. It involved 122 patients who were randomized to receive either licaminlimab or a vehicle for six weeks, followed by a two-week follow-up. The study also had a specific focus on a subpopulation of 23 patients with a TNFR1-related genotype. Efficacy endpoints were assessed at baseline, Day 15, and Day 43.

Efficacy and Safety Findings:

1. General Population: Across the full study population, licaminlimab showed positive effects on various DED signs, including improvements in fluorescein staining across the total cornea, inferior corneal, central corneal, and nasal conjunctival regions, as well as in the Schirmer’s test.

2. TNFR1 Genetic Biomarker Subpopulation: For patients with the TNFR1 genetic biomarker, licaminlimab displayed significant benefits in several endpoints, such as fluorescein staining in the total cornea, inferior corneal, central corneal, nasal conjunctival, total conjunctival, and total ocular surface regions. The Schirmer’s test and conjunctival redness also showed marked improvement.

3. Rapid Onset: The treatment effects on corneal inflammation were noticeable as early as Day 15 and were statistically significant by Day 43. The mean change from baseline in inferior corneal fluorescein staining score was -0.59 compared to the vehicle group, with the treatment effect growing over time.

Licaminlimab was well tolerated, with mild and transient ocular treatment-emergent adverse events (TEAEs). The incidence of TEAEs in both the study and fellow eyes was comparable between the licaminlimab and vehicle groups, and no serious ocular adverse events were reported.

Expert Opinions:

Riad Sherif, MD, CEO of Oculis, expressed satisfaction with the trial's outcomes, noting licaminlimab's potential to revolutionize drug development and patient care in ophthalmology through a precision medicine approach. Eric Donnenfeld, M.D., a Clinical Professor of Ophthalmology at New York University, highlighted licaminlimab's potential to shift from a "trial and error" method to a predictable treatment for DED, addressing a significant unmet need. Christophe Baudouin, M.D., Ph.D., emphasized that licaminlimab’s dual mechanism of action targets the root causes of DED, showing potential as a disease-modifying treatment.

Oculis plans to discuss the Phase 3 development strategy for licaminlimab with the U.S. Food and Drug Administration (FDA) in an end-of-Phase 2 meeting. This discussion aims to chart the path for licaminlimab's future development.

About Dry Eye Disease (DED):

DED is an inflammatory condition affecting approximately 40 million people in the U.S. It involves symptoms like stinging, burning, and sensitivity to light, causing significant discomfort and impacting the quality of life. Despite existing treatments, many patients remain unsatisfied, underscoring the need for more effective and personalized therapeutic options.

About Licaminlimab (OCS-02):

Licaminlimab is an investigational anti-TNFα eye drop designed to treat ocular inflammatory diseases. It leverages a single chain antibody fragment (scFv) technology, offering dual anti-inflammatory and anti-necrotic benefits. Previous studies have shown that licaminlimab improves both signs and symptoms of DED, with a specific genetic biomarker (TNFR1) correlating with enhanced treatment response.

Oculis remains dedicated to advancing licaminlimab through the clinical pipeline, aiming to provide a transformative treatment for DED patients globally.

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