Oculis starts Privosegtor optic neuritis trial
- Oculis announced that the first patient has been treated in PIONEER-1, a registrational trial evaluating Privosegtor for acute optic neuritis.
- The trial will measure visual outcomes, including the proportion of patients achieving at least a 15-letter visual acuity improvement at Month 3.
- Oculis stated that positive results could support a future regulatory submission for Privosegtor in optic neuritis.
Oculis (NASDAQ:OCS) announced that the first patient has been treated in PIONEER-1, a registrational trial evaluating Privosegtor for acute optic neuritis in patients with and without multiple sclerosis.
The PIONEER-1 study is part of the broader PIONEER program and follows earlier Phase 2 ACUITY results, which Oculis stated showed vision and neuroprotective benefits for Privosegtor.
The primary endpoint measures the percentage of patients achieving at least a 15-letter gain in visual acuity at Month 3, while a key secondary endpoint evaluates changes in low-contrast visual acuity, with patients followed through Month 12 for safety.
Oculis stated that the PIONEER-1 trial design and planned analysis are covered by a U.S. Food and Drug Administration Special Protocol Assessment.
Oculis is developing Privosegtor as a potential treatment for neuro-ophthalmic conditions, with the company also planning an Investigational New Drug submission in Q4 2026 to study the medicine in acute multiple sclerosis relapses.
Optic neuritis is an inflammatory condition affecting the optic nerve and is often associated with multiple sclerosis, while current treatment options focus mainly on managing inflammation rather than providing approved neuroprotective therapy.
