Oculis Begins Phase 2b RELIEF Trial of Topical Anti-TNFα Licaminlimab (OCS-02) in Dry Eye Disease

Oculis announced 'First Patient First Visit' (FPFV) in its phase 2b RELIEF trial evaluating the potential of licaminlimab (also known as OCS-02), Oculis’ anti-TNFα biologic eye drop drug candidate for the treatment of dry eye disease (DED).

The phase 2b RELIEF trial is a multicenter, randomized, double-masked, vehicle-controlled trial evaluating the safety and efficacy of licaminlimab for the treatment of signs and symptoms in moderate-to-severe DED. The trial will evaluate if patients with a specific genetic biomarker identified in a prior trial respond better to licaminlimab. The trial was designed after several trials with licaminlimab in DED and uveitis demonstrated positive findings. The trial will enroll 120 patients randomized to either licaminlimab or vehicle for a 6-week treatment and a 2-week follow up period. Topline results are anticipated in mid-2024.

“We are very pleased to have achieved First Patient First Visit (FPFV) in the RELIEF trial as planned. The initiation of this trial represents a key milestone as we advance the development of OCS-02, a promising, differentiated candidate in dry eye," Riad Sherif, MD, Chief Executive Officer of Oculis, said in a company news release. "This achievement builds on our earlier successes this year with positive phase 3 results from our other lead asset, OCS-01, in diabetic macular edema and post ocular surgery. DED remains an area of unmet medical need with only 13% of patients achieving lasting relief after 12 months of treatment in a large and growing market affecting approximately 40 million patients in the US. We are confident that licaminlimab, given its proven mechanism of action and its prior clinical trials results, will have transformative potential in DED. We look forward to sharing the topline results in mid-2024.”

“Patients with DED, especially in its severe form, experience considerable impact on their quality of life due to the significant pain and discomfort it causes, among other signs and symptoms. Unfortunately, currently available treatments only provide lasting relief for a small portion of the patient population, and as a result, new treatment approaches are needed," Christophe Baudouin, MD, Professor of Ophthalmology and Chairman of Ophthalmology III at Quinze-vingts National Ophthalmology Hospital, Paris, and member of Oculis Scientific Advisory Board, said in the news release. "Licaminlimab leverages the already proven mechanism of action (MOA) of anti-TNFα which could be very beneficial given the central role of ocular surface inflammation in DED. In fact, it’s been shown that tears from DED patients contain increased concentrations of inflammatory cytokines, such as TNFα, that are correlated to disease severity. I believe that the anti-inflammatory and anti-apoptotic effects of blocking TNFα could potentially revolutionize the treatment of several inflammatory eye conditions, similarly to what anti-TNFα treatments have shown in other therapeutic areas.”