Oculis secures FDA agreement on trial design for Privosegtor to treat optic neuritis, advancing neuroprotective therapy development.

Oculis Holding AG announced it has received a Special Protocol Assessment (SPA) agreement from the U.S. FDA for its Phase 3 PIONEER-1 trial of Privosegtor, a novel neuroprotective drug for optic neuritis (ON). This agreement confirms the trial design meets FDA requirements to support a future New Drug Application if successful. Privosegtor has shown promising results in earlier trials, improving vision and protecting nerve cells, and has received Breakthrough Therapy and PRIME designations, highlighting its potential to address a significant unmet medical need. The PIONEER-1 trial will enroll a broad patient population and assess vision improvement and safety over 12 months, aiming to bring the first neuroprotective treatment for ON to market.