Oculis S.A. missed statistical significance in most signs of dry eye disease in the 122-patient RELIEF study of licaminlimab (OCS-2), but the trial did reach statistical significance in a biomarker-identified subgroup on one sign of the disease, corneal inflammation, and the company believes that the positive trends overall support moving into Phase III.
Key Takeaways
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Oculis is planning to target inflammation and apoptosis in dry eye disease with its novel anti-TNFα eye drop licaminlimab.
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The Swiss biotech would like to plan a Phase III protocol with the FDA even though the drug only met statistical significance on one endpoint in a genetic subgroup in a Phase II trial, with favorable trends overall
During a same-day call, Oculis CEO Riad Sherif talked about convening an end-of-Phase II meeting with the US Food and Drug Administration to design a Phase III program for licaminlimab in dry eye, citing two previous Phase II studies in symptoms of the disease as well as the identification of a TNF receptor 1 (TNFR1) genotype
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