USFDAAug 3, 2026, 04:01 AM
Oculis gets positive FDA feedback for Privosegtor in acute MS relapses
AI Summary
Oculis Holding AG announced positive U.S. Food and Drug Administration (FDA) pre-IND feedback for Privosegtor's clinical development plan in acute multiple sclerosis (MS) relapses. The FDA confirmed that existing data can be cross-referenced for a new Investigational New Drug (IND) application, which Oculis plans to submit in the fourth quarter of 2026. This feedback supports a regulatory pathway for Privosegtor, a novel neuroprotective candidate, to address a significant unmet medical need in MS relapses. Oculis will host a virtual R&D Day in Q4 2026 to provide further updates on its clinical pipeline.
Key Highlights
- FDA provided positive feedback for Privosegtor in acute MS relapses.
- Existing Privosegtor data can be cross-referenced for a new IND application.
- IND submission for acute MS relapses is planned for Q4 2026.
- FDA supported the proposed clinical development strategy and regulatory pathway.
- FDA supported a primary endpoint as early as 3 months for trials.
- Oculis will host a virtual R&D Day in Q4 2026 for pipeline updates.
- Privosegtor is a novel neuroprotective candidate addressing unmet medical needs.
- Privosegtor holds Breakthrough Therapy and PRIME designations for optic neuritis.
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