First patient visit complete in phase 2b RELIEF trial of licaminlimab for dry eye disease
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Oculis has announced the first patient first visit in its phase 2b RELIEF trial evaluating licaminlimab, the company’s novel anti-tumor necrosis factor-alpha biologic eye drop, for treatment of moderate to severe dry eye disease.
“Licaminlimab is a promising topical candidate, which has already shown strong data in two prior trials with over 215 patients, where it demonstrated superiority over vehicle in alleviating ocular discomfort in patients with severe DED while also being well-tolerated,” Eric Donnenfeld, MD, clinical professor of ophthalmology at New York University and co-chair of the Oculis scientific advisory board, said in a company press release. “Another unique finding from a prior phase 2a trial was the discovery of a genetic biomarker that may help identify high responders to licaminlimab, which we look forward to exploring in the RELIEF trial.”
According to the release, the multicenter, randomized, double-masked trial will evaluate the safety and efficacy of licaminlimab vs. vehicle, as well as determine whether patients previously identified as having the biomarker respond better to treatment. The study will include 120 participants for a 6-week treatment period and a 2-week follow up.
“We are confident that licaminlimab, given its proven mechanism of action and its prior clinical trials results, will have transformative potential in DED,” Riad Sherif, MD, Oculis CEO, said in the release. “We look forward to sharing the topline results in mid-2024.”
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