Clinical TrialJun 9, 2026, 04:01 AM
Oculis Randomizes First Patient in PREDICT-1 Dry Eye Trial
AI Summary
Oculis Holding AG announced the randomization of the first patient in the PREDICT-1 genotype-based registrational trial for Licaminlimab in dry eye disease (DED). This FDA-aligned trial targets a specific TNFR1 genotype, aiming to deliver a first-in-class precision medicine. The study plans to enroll approximately 160 patients, with about two-thirds carrying the specified genotype. If approved, Licaminlimab has the potential to transform DED treatment, addressing a market where only 13% of patients find sustained relief and discontinuation rates are high, leveraging promising Phase 2 results.
Key Highlights
- First patient randomized in PREDICT-1, a genotype-based registrational trial for Licaminlimab in dry eye disease (DED).
- The trial targets a specific TNFR1 genotype, aiming for a first-in-class precision medicine treatment.
- Approximately 70% of clinical sites are activated, with patients already in the run-in phase.
- PREDICT-1 plans to enroll ~160 patients, with ~2/3 expected to have the specified TNFR1 genotype.
- Only 13% of DED patients experience sustained relief with current treatments, highlighting unmet need.
- Licaminlimab showed a 5-7x more pronounced treatment effect in Phase 2 for patients with the TNFR1 genotype.
- Approximately 10 million diagnosed patients in the U.S. suffer from moderate to severe DED.
Price Impact
More from OCS