Oculis secures FDA agreement on trial design for Privosegtor in optic neuritis treatment

Oculis Holding AG has received FDA Special Protocol Assessment (SPA) approval for its Phase 3 PIONEER-1 trial of Privosegtor, a novel neuroprotective drug for optic neuritis (ON). This agreement confirms the trial design is suitable to support a future New Drug Application if results are positive. Privosegtor has shown promise in earlier trials and holds FDA Breakthrough Therapy and EMA PRIME designations, highlighting its potential to address a significant unmet need in neuro-ophthalmology. The PIONEER-1 trial will assess visual improvement and long-term safety in patients, including those with multiple sclerosis, aiming to offer the first neuroprotective therapy for ON.