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

Oculis Holding AG, a global biopharmaceutical company, has reported positive results from its Phase 2b RELIEF trial for licaminlimab, a novel anti-TNFα biologic eye drop for dry eye disease (DED). The trial demonstrated significant improvements in multiple signs of DED, particularly in patients with a specific TNFR1 genetic biomarker.

The Phase 2b RELIEF trial was a multi-center, randomized, double-masked, vehicle-controlled study that assessed the efficacy and safety of licaminlimab. The trial included 122 patients who were randomly assigned to either licaminlimab (62 patients) or a vehicle (60 patients) for a six-week treatment period, followed by a two-week follow-up. Among these participants, 23 carried a specific TNFR1-related genotype. Patients were evaluated at baseline, Day 15, and Day 43 using multiple efficacy endpoints recognized by the FDA.

For the entire population, licaminlimab showed favorable treatment effects on multiple DED signs, including fluorescein staining in various corneal regions and the Schirmer’s test. In the subpopulation with the TNFR1 genetic biomarker, licaminlimab demonstrated significant treatment effects on additional endpoints, including total ocular surface regions and conjunctival redness. Notably, a rapid and significant reduction in corneal inflammation was observed in TNFR1 genetic biomarker patients as early as Day 15, with further improvements by Day 43.

Licaminlimab was well tolerated, with mild and transient ocular treatment-emergent adverse events (TEAEs) similar to the vehicle group. No serious ocular adverse events were reported, and the comfort of the eye drop was comparable to artificial tears.

Riad Sherif, M.D., CEO of Oculis, expressed satisfaction with the trial results, highlighting the potential of licaminlimab’s precision medicine approach to transform ophthalmology treatments. Dr. Eric Donnenfeld, a Clinical Professor at New York University, emphasized the potential paradigm shift that licaminlimab represents for treating DED, moving away from the current trial-and-error approach. Dr. Christophe Baudouin, a Professor of Ophthalmology, noted the drug’s potential to modify the disease by targeting its underlying causes.

Oculis plans to engage in an end-of-Phase 2 meeting with the FDA to discuss the pathway for licaminlimab’s registration and finalize plans for Phase 3 development.

DED is a widespread condition affecting nearly 40 million people in the U.S. as of 2023. It is characterized by ocular surface inflammation, leading to discomfort and vision issues. Despite available treatments, a significant number of patients remain unsatisfied, highlighting the need for more effective and personalized treatment options.

Licaminlimab, also known as OCS-02, is an investigational anti-TNFα eye drop designed to treat ocular inflammatory diseases. It employs a dual anti-inflammatory and anti-necrotic mechanism. The drug has shown positive effects in multiple Phase 2 trials and a correlation between a TNFR1 gene variant and improved patient response.

Oculis, headquartered in Switzerland, focuses on innovative treatments for eye care. The company’s pipeline includes several promising candidates, such as OCS-01 for diabetic macular edema and post-cataract surgery inflammation and pain, and OCS-05 for acute optic neuritis. The company is committed to improving the quality of life for patients with eye diseases.

The Oculis management team will discuss the trial results in an analyst and investor call, available via webcast. The company will provide a replay of the webcast and accompanying slides for 90 days following the event.