Oculis teased that its dry eye disease therapy worked in a mid-stage trial, but it stopped short of reporting statistically significant data across most endpoints.
The ophthalmology biotech identified a treatment effect “favoring” licaminlimab across a number of cornea staining assessments, finding a larger benefit in a specific genetic subgroup of patients, according to results released on Monday. The primary endpoint of the study was total cornea staining.
Licaminlimab’s improvement versus a vehicle was seen in the total cornea, inferior corneal, central corneal and nasal conjunctival regions for both the full study population and the TNFR1-specific subgroup. In the biomarker subgroup, the treatment improved staining in the total conjunctival and total ocular surface regions. Oculis also said the treatment effect favors licaminlimab in both the Schirmer’s test — a measure of eye moisture — and eye redness.
The company stopped short of saying the data were statistically significant compared to a vehicle. The best data came from inferior corneal staining among patients in the TNFR1 subgroup, with Oculis reporting a p-value less than 0.05 compared to vehicle at day 43, the last day of treatment. The treatment effect favored the vehicle in the full study population across total conjunctival staining, total ocular surface staining and conjunctival redness endpoints.
Oculis said licaminlimab was well-tolerated and no serious ocular adverse effects were reported. CEO Riad Sherif said in a statement that he looks forward to bringing the data to the FDA, and it plans to launch a Phase 3 study.
The data shore up Oculis’ pipeline after its lead asset, called OCS-01, delivered positive Phase 3 data in August that showed the therapy improved inflammation and pain in patients after they underwent post-ocular surgery. About a year ago, Oculis reported that OCS-01 was successful in the first part of a multi-pronged Phase 3 study for patients with diabetic macular edema.
Oculis raised a fresh $59 million equity offering in April to progress these programs, extending its runway into the second half of 2026. The biotech had $88.7 million on hand as of the end of March, according to its first-quarter earnings update.