Oculis is forging ahead with its precision medicine approach to treating dry eye disease, outlining plans to finalize a phase 3 study after seeing some signs of efficacy in a subpopulation in its midstage trial.
Investigators randomized 122 dry eye disease patients to receive the anti-TNFα eye drop licaminlimab, also known as OCS-02, or placebo. The study included 23 people with a genotype that Oculis previously linked to responses to its drug candidate. Oculis included the subpopulation to provide further validation of a biomarker that could support a diagnostic-enabled precision medicine approach for licaminlimab.
The company reported data from the phase 2b study Monday. Oculis breezed past the results from the overall population, noting a “treatment effect favoring licaminlimab” on the total cornea staining primary endpoint and other measures without commenting on statistical significance.
Rather than dwell on the overall data, Oculis focused its press release on the subpopulation of 23 people with a specific TNFR1-related genotype. The company reported a treatment effect favoring licaminlimab on cornea staining and in a test of tear production, mirroring its comments for the overall population, and added conjunctival redness to the measures where its molecule may have an edge in the subgroup.
Oculis reported a statistically significant result on one secondary endpoint, at one time point, in the subpopulation. Corneal inflammation favored licaminlimab after 15 days, and the difference was significant after 43 days.
Based on the results, the company plans to talk to the FDA about the path to market and finalize the design of its phase 3 study. Oculis CEO Riad Sherif, M.D., said in a statement that the precision medicine approach could “transform the way we develop drugs and treat patients in ophthalmology.”
Oculis acknowledged the risks of breaking new ground in its annual financial filing, warning investors that the effectiveness of the strategy “partially depends on the successful development of both OCS-02 and a companion diagnostic for the biomarker.” If successful, Oculis will compete with companies such as AbbVie, Alcon, Bausch + Lomb, Viatris and Sun Pharmaceuticals.