Oculis targets Q4 2026 Privosegtor MS filing

• Oculis received positive FDA pre-IND feedback supporting Privosegtor’s development for acute multiple sclerosis relapses.
• Oculis shares were up 0.71% at $11.31 in the latest available trading.
• The company expects to submit a new IND in Q4 2026 using existing Privosegtor data.

Oculis (NASDAQ:OCS) received positive FDA feedback supporting Privosegtor’s development for acute multiple sclerosis relapses, where the company said no neuroprotective therapy is approved.

The FDA confirmed that Oculis may cross-reference existing Privosegtor data and will not need additional preclinical studies for the proposed IND.

The proposed clinical program would enroll patients with optic neuritis and other acute relapse types, with its primary endpoint assessed after three months.

Oculis plans to use 3 mg/kg daily for five days, matching PIONEER-1, and expects to discuss the program at a virtual R&D Day in Q4 2026.

Following the announcement, Oculis's share price was up 0.71% at $11.31.

Oculis is already evaluating Privosegtor in the registrational PIONEER-1 and PIONEER-2 optic neuritis trials, which include patients with and without multiple sclerosis.

Privosegtor has FDA Breakthrough Therapy and EMA PRIME designations for optic neuritis, although its safety and effectiveness remain under clinical evaluation.