Oculis Completes PREDICT-1 Randomization for Dry Eye Drug

ZUG, Switzerland, October 19, 2026

Genotype-Guided Trial Targets Patients More Likely to Respond

PREDICT-1 is designed to evaluate licaminlimab’s effect on dry eye symptoms in patients carrying the specified TNFR1 genotype, while also assessing efficacy and safety in the overall study population. The primary endpoint is the change from baseline at Day 29 in the global ocular discomfort severity score among patients with the target genetic variant. The same measure will be evaluated in the overall population as a key secondary endpoint. The study builds on earlier Phase 2 findings in which licaminlimab demonstrated improvements in both the signs and symptoms of dry eye disease, including a statistically significant reduction in ocular discomfort compared with vehicle at Day 29 in a prior symptoms trial. A rapid onset of action was observed as early as Day 14. Oculis also reported a more pronounced treatment effect among patients with the specified TNFR1 genotype. According to CEO Riad Sherif, M.D., the completion of randomization represents an important operational milestone as the company advances toward the planned data readout. The trial is intended to test whether the earlier genotype-associated findings can be validated in a registrational study.

Licaminlimab and the Role of TNFR1 in Dry Eye Disease

Licaminlimab is an investigational anti-TNFα eye drop candidate developed using single-chain antibody fragment (scFv) technology to target ocular inflammatory diseases. TNFR1 is a receptor involved in tumor necrosis factor alpha (TNFα)-mediated inflammation and cell-death signaling. Oculis’ development strategy is based on evidence from earlier studies suggesting that genetic variation in the TNF/TNFR1 pathway may contribute to differences in inflammatory responses and treatment outcomes. In Phase 2 trials, patients with a particular TNFR1 genotype showed a stronger clinical response to licaminlimab, providing the rationale for selecting this subgroup in PREDICT-1. A genetic biomarker test could potentially help clinicians identify patients more likely to benefit from the treatment, rather than relying exclusively on trial-and-error prescribing. Anat Galor, M.D., M.S.P.H., Professor of Ophthalmology at the Bascom Palmer Eye Institute, noted that dry eye disease varies considerably between patients and that a precision medicine approach could help improve treatment selection. The PREDICT-1 results will be important in determining whether this targeted strategy can demonstrate clinical benefit in a larger, controlled study.

Large Unmet Need in Moderate-to-Severe Dry Eye Disease

Dry eye disease is a multifactorial condition involving disruption of the ocular surface and inflammation. Symptoms may include burning, stinging, scratchiness, redness, light sensitivity and blurred vision, potentially affecting daily activities and quality of life. Oculis estimates that approximately 40 million people in the United States have dry eye disease, with around 10 million experiencing moderate-to-severe disease requiring active treatment. The company estimates that approximately 13% to 19% of patients with moderate-to-severe DED carry the relevant TNFR1 genetic variant, representing roughly 1.3 million to 1.9 million potential patients in the United States. Current treatment management can involve repeated attempts to find a suitable therapy, and many patients report inadequate or unsustained relief. If the PREDICT-1 trial demonstrates a positive benefit-risk profile and subsequent regulatory requirements are met, licaminlimab could potentially introduce a genotype-guided treatment option for this patient subgroup. However, licaminlimab remains investigational and has not been approved for commercial use in any country. Oculis expects the anticipated year-end 2026 topline results to provide the next major update on the program’s clinical development.

Source::Oculis,,press release