Licaminlimab (OCS-02) - (PREDICT-1)

June 09, 2026: Oculis Holding AG (NASDAQ: OCS) announced the first patient has been randomized in PREDICT-1, a genotype-based registrational (pivotal) clinical trial of licaminlimab, an investigational topical anti-TNFα eye drop, in dry eye disease (DED). The FDA-aligned, randomized, multicenter, double-masked, vehicle-controlled study plans to enroll ~160 patients, with ~2/3 carrying a specified TNFR1 genotype.

PREDICT-1’s primary endpoint is change from baseline to Day 29 in global ocular discomfort severity score in the specified TNFR1 genotype population; the same measure in the overall population is a key secondary endpoint. The protocol includes a screening phase to select patients by TNFR1 genotype and symptom severity (global ocular discomfort severity score ≥60) assessed before and after an artificial tear run-in.

The company cited prior Phase 2 results showing greater clinical response in patients with a specific TNFR1 genotype and noted licaminlimab remains unapproved for commercial use.