Oculis Holding AG announced that it has completed randomization in the PREDICT-1 genotype-based registrational trial of licaminlimab for dry eye disease (DED), with topline results expected around year-end 2026.

Licaminlimab is an investigational topical anti-TNFα therapy being developed as a genotype-guided treatment for DED.

According to the company, PREDICT-1, the program's first registrational trial, is designed to evaluate the efficacy of licaminlimab compared with vehicle in reducing DED symptoms among patients carrying a specific TNFR1 genotype, while also assessing its effects and safety in the overall study population.

Oculis reported enrolling 176 patients in the randomized, multicenter, double-masked, vehicle-controlled study, approximately two-thirds of whom carry the specified TNFR1 genotype. The primary endpoint is the 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 be evaluated in the overall study population as a key secondary endpoint.

In a prior phase 2 trial evaluating DED symptoms, patients treated with licaminlimab experienced a statistically significant reduction in ocular discomfort compared with vehicle at day 29, with improvement observed as early as day 14, according to the company. OM