Privosegtor - (PIONEER-1)

August 24, 2026: Oculis Holding AG (NASDAQ: OCS) said the first patient has been treated in PIONEER-1, a registrational trial of Privosegtor for acute optic neuritis (ON). PIONEER-1 is enrolling a broad ON population, including patients with and without multiple sclerosis, and is intended to support registration.

The trial’s primary endpoint is the proportion of patients achieving at least a 15-letter gain from baseline at Month 3; a secondary endpoint is mean change in low-contrast visual acuity at Month 3. Patients will be followed through Month 12 for safety and tolerability. Oculis said the FDA has provided a Special Protocol Assessment agreeing that the trial design and planned analysis can support an NDA submission in ON, subject to a successful outcome and full NDA review.

The company said PIONEER-1 follows the Phase 2 ACUITY trial, in which Privosegtor showed vision improvements at Month 3 that persisted through Month 6 by low-contrast visual acuity, along with anatomical and biological neuroprotective benefits versus placebo. Oculis said these data supported FDA Breakthrough Therapy, FDA/EMA Orphan Drug, and EMA PRIME designations for ON.

Upcoming catalyst: Oculis plans an IND submission in Q4 2026 for Privosegtor in acute MS relapses following FDA pre-IND feedback.