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.
Oculis Looks To Move Dry Eye Candidate To Phase III Despite Mixed Dataset
Oculis’s licaminlimab showed ability to treat a sign of dry eye disease in a genetic subpopulation, but data in the fuller Phase IIb trial enrollment were less impressive.
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A decision from the FDA is due by 28 September.