Oculis Outlines Genotype-Based Dry Eye Strategy

Clinical Report: Oculis Outlines Genotype-Based Dry Eye Strategy

Overview

At AAO 2026, Oculis CEO Riad Sherif described licaminlimab, a TNF-α inhibitor being developed for TNFR1-mediated dry eye disease, and the genotype-based approach in phase 3 PREDICT-1. The trial is expected to include approximately two-thirds of participants with a specified TNFR1 genotype, and topline results are expected around year-end.

Background

Dry eye disease is described by Sherif as a substantial unmet medical need, with a small percentage of patients responding to current treatments. The Oculis program is designed around a specific TNFR1 genotype, selecting genetically positive patients for study of licaminlimab. Broader dry eye guidance has also moved toward mechanism-based classification and management: TFOS DEWS III updates definitions, subclassification, and diagnostic approaches, while the American Academy of Ophthalmology’s 2024 Preferred Practice Pattern provides staged recommendations for diagnosis and management.

Data Highlights

Item	Reported information
Investigational therapy	Licaminlimab, a TNF-α inhibitor being developed for TNFR1-mediated dry eye disease
Trial	Phase 3 PREDICT-1
Genotype strategy	The development approach tests patients for a specified TNFR1 genotype; patients positive for the genotype are included in the trial
Expected genotype composition	Approximately two-thirds of trial participants are expected to have the specified genotype
Timing	Topline results expected around year-end, as stated at AAO 2026

Key Findings

Licaminlimab is a TNF-α inhibitor being developed for TNFR1-mediated dry eye disease, according to Oculis CEO Riad Sherif.
PREDICT-1 is a phase 3 trial using a genotype-based development approach.
The trial includes patients positive for a specified TNFR1 genetic variant.
Approximately two-thirds of trial participants are expected to have the specified genotype.
Sherif said topline results were expected around year-end.

Clinical Implications

The source describes PREDICT-1’s genotype-based development approach and anticipated readout. It does not report efficacy or safety results for licaminlimab.

Conclusion

Oculis is evaluating licaminlimab in phase 3 PREDICT-1 using a genotype-based development approach. The source reports the trial design and anticipated readout, but provides no outcome data.