Oculis Advances Precision Dry Eye Treatment as First Patient Enrolls in 160-Patient Trial
OCS•Oculis randomized the first patient in its 160-patient PREDICT-1 trial of Licaminlimab, enrolling two-thirds of participants with a specific TNFR1 genotype. With 70% of sites activated and just 13% of patients achieving sustained relief, the study seeks to prove a genotype-focused treatment for over 10 million moderate-to-severe sufferers.
1. First Patient Randomized in Registrational Trial
Oculis has enrolled and randomized the first patient in its PREDICT-1 registrational study of Licaminlimab for dry eye disease. The randomized, double-masked, vehicle-controlled trial plans to enroll about 160 patients, with two-thirds carrying a targeted TNFR1 genotype.
2. Genotype-Focused Precision Medicine Approach
The study screens participants for a specific TNFR1 variant before randomization to maximize treatment effects, leveraging phase 2 data showing a five- to seven-fold greater response in genotype-positive patients. Approximately 70% of clinical sites are activated and patients are currently in the run-in phase.
3. Large Unmet Need and Market Potential
In the U.S. alone, an estimated 10 million patients suffer moderate-to-severe dry eye disease, yet only 13% achieve sustained relief under current therapies. Licaminlimab’s precision approach aims to address this 85-90% discontinuation rate and could reshape the treatment paradigm if approved.
