Key Takeaways
- Oculis completed randomization of its PREDICT-1 clinical trial of licaminlimab for the treatment of dry eye disease.
- The PREDICT-1 trial will evaluate the efficacy of licaminlimab in patients with and without the tumor necrosis factor receptor 1 geneotype.
- In a previous study, patients treated with licaminlimab experienced a statistically significant reduction in ocular discomfort compared with vehicle at day 29.
Oculis announced completion of randomization in the phase 2 PREDICT-1 clinical trial of licaminlimab, the first genotype-based registrational trial in dry eye disease (DED). The company expects to report topline results around the end of 2026.
PREDICT‑1 is designed to evaluate the efficacy of licaminlimab in treating symptoms of DED compared with a vehicle in patients carrying a specific tumor necrosis factor receptor 1 (TNFR1) genotype, while also assessing its effectiveness and safety in the overall study population. A total of 176 patients have been enrolled in this randomized, multicenter, double-masked, vehicle-controlled study, two-thirds of whom have the specified TNFR1 genotype. The primary endpoint is change from baseline at day 29 in the global ocular discomfort severity score in patients with the specified TNFR1 genotype. The same outcome measure will also be evaluated in the overall study population as a key secondary endpoint.
In a previous phase 2 trial, patients treated with licaminlimab experienced a statistically significant reduction in ocular discomfort compared with vehicle at day 29, with a rapid onset of action observed as early as day 14.5.
