Oculis Randomizes First Patient in Licaminlimab PREDICT-1 DED Trial
Oculis Holding AG announced the randomization of the first patient in its PREDICT-1 genotype-based registrational trial for Licaminlimab in dry eye disease (DED). This trial represents the first genotype-based registrational study in DED, aiming to deliver a precision medicine treatment by targeting a specific TNFR1 genotype. With approximately 10 million diagnosed patients in the U.S. suffering from moderate to severe DED and only 13% experiencing sustained relief from current therapies, Licaminlimab has the potential to address a significant unmet medical need. The trial plans to enroll around 160 patients, with a primary endpoint evaluating global ocular discomfort severity in patients with the specified TNFR1 genotype.
Key Highlights
- Oculis randomized the first patient in the PREDICT-1 genotype-based registrational trial for Licaminlimab in dry eye disease (DED).
- PREDICT-1 is the first genotype-based registrational trial in DED, targeting the specific TNFR1 genotype.
- Approximately 70% of clinical sites are already activated, with patients in the run-in phase.
- The trial plans to enroll approximately 160 patients, with about two-thirds having the specified TNFR1 genotype.
- Licaminlimab demonstrated greater clinical response in patients with a specific TNFR1 genotype in Phase 2 trials.
- About 10 million diagnosed patients in the U.S. suffer from moderate to severe DED.
- Only 13% of DED patients experience sustained relief with current treatments.
- Current DED treatments have an 85-90% discontinuation rate within the first 6 months.
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