Oculis targets dry eye disease with phase 3 trial

Oculis, a company dedicated to advancing precision medicine for dry eye disease, is preparing to engage with the FDA to discuss its market strategy and finalize the design for a phase 3 study. This decision follows promising indications from a midstage trial, particularly within a specific subpopulation.

The phase 2b study involved 122 patients diagnosed with dry eye disease, who were randomized to receive either the anti-TNFα eye drop licaminlimab (also known as OCS-02) or a placebo. The trial included a targeted subgroup of 23 individuals possessing a genotype previously identified by Oculis as responsive to the drug. This subgroup was crucial for validating a biomarker that could support a precision medicine approach, potentially enabling a diagnostic-driven treatment strategy for licaminlimab.

Oculis highlighted the treatment's favorable effects on the primary endpoint of total corneal staining, as well as other measures, although they did not provide detailed statistical significance for the overall population results. Instead, the company emphasized the outcomes within the subpopulation with the specific TNFR1-related genotype. In this group, licaminlimab showed positive effects on corneal staining and tear production, consistent with the overall population results, and also demonstrated potential benefits in reducing conjunctival redness.

Notably, a statistically significant result emerged for one secondary endpoint within the subpopulation: corneal inflammation. This marker showed a significant improvement in favor of licaminlimab at the 15-day mark and maintained significance after 43 days.

These findings have prompted Oculis to proactively seek a dialogue with the FDA to discuss the pathway to market approval and to solidify the design plans for their upcoming phase 3 study. Dr. Riad Sherif, CEO of Oculis, expressed optimism about the precision medicine approach, suggesting it could revolutionize drug development and patient treatment in ophthalmology.

However, Oculis is also aware of the inherent risks associated with pioneering new medical strategies. In its annual financial report, the company cautioned investors that the success of its approach relies heavily on the effective development of both the drug OCS-02 and a companion diagnostic for the biomarker. Success in this area would position Oculis against established competitors such as AbbVie, Alcon, Bausch + Lomb, Viatris, and Sun Pharmaceuticals.

In summary, Oculis is advancing its precision medicine initiative for treating dry eye disease by focusing on a targeted subpopulation that has shown a favorable response to licaminlimab. The company is preparing to consult with the FDA and finalize its phase 3 study design, with hopes of transforming therapeutic approaches in ophthalmology. Despite the potential challenges, Oculis is determined to lead the way in this innovative medical frontier.