# Oculis Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Optic Neuritis Registrational Trial
Canonical URL: https://biopharmsignal.com/news/OCS/oculis-announces-agreement-with-fda-on-a-special-protocol-assessment-spa-for-optic-neuritis-registrational-trial
Ticker: OCS
Company: Oculis
Source: Oculis
Published: 2026-05-07 08:58 EST
Original Source URL: https://investors.oculis.com
## Summary

Special Protocol Assessment (SPA) agreement with the U.S. FDA provides regulatory alignment on the registrational path for Privosegtor in optic neuritis (ON) FDA Breakthrough Therapy and EMA PRIME designations in ON underscore the significant unmet need and therapeutic potential of Privosegtor as a

## Article Body
Special Protocol Assessment (SPA) agreement with the U.S. FDA provides regulatory alignment on the registrational path for Privosegtor in optic neuritis (ON) FDA Breakthrough Therapy and EMA PRIME designations in ON underscore the significant unmet need and therapeutic potential of Privosegtor as a
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