Oculis Completes Randomization in PREDICT-1 Registrational Trial of Licaminlimab for TNFR1-Mediated Dry Eye Disease

Riad Sherif, Chief Executive Officer of Oculis

“Completing randomization in such a timeframe with a new modality demonstrates that genotype-driven development is crucial and precision medicine is urgently needed in DED. PREDICT-1 is an important operational milestone as we track toward topline results around year-end 2026. In prior Phase 2 studies, Licaminlimab showed robust improvement across both signs and symptoms of dry eye disease, with an amplified response in patients harboring a specific TNFR1 genotype. Importantly, a simple, non-invasive genetic biomarker test can identify this patient population, supporting the practical application of this precision medicine approach. PREDICT-1 builds directly on that scientific rationale to validate our genotype-guided strategy. If successful, Licaminlimab has the potential to pioneer a first-in-class precision medicine treatment paradigm, delivering targeted relief to a large, underserved patient population with TNFR1-driven disease.”

Anat Galor, Professor of Ophthalmology, Bascom Palmer Eye Institute, Miami

“Dry eye disease is a highly heterogeneous condition, and treatment response can vary considerably between patients. As a result, selecting the right therapy often involves a lengthy trial-and-error process that can lead to patient dissatisfaction and early treatment discontinuation. A precision medicine approach to identify individuals more likely to benefit from a specific therapy could meaningfully advance care for both patients and clinicians. The findings observed in earlier studies of Licaminlimab provide a compelling rationale for the PREDICT-1 trial, and I look forward to seeing whether this targeted approach can advance a more effective treatment paradigm and improve outcomes for patients living with dry eye disease.”