ZUG, Switzerland, Aug. 3, 2026
Oculis announced that the U.S. Food and Drug Administration (FDA) has provided positive pre-Investigational New Drug (pre-IND) feedback supporting the clinical development strategy for Privosegtor as a potential treatment for acute multiple sclerosis (MS) relapses. The FDA confirmed that Oculis can cross-reference existing Privosegtor data from its ongoing development program and that no additional preclinical studies are required before submitting a new IND application, which the company plans to file in the fourth quarter of 2026. The agency also supported the proposed regulatory pathway, including evaluating both optic neuritis and other ambulatory MS relapses using a primary endpoint at three months and the same 3 mg/kg dose administered over five days currently being studied in the PIONEER-1 trial.
FDA Feedback Supports Expansion Beyond Optic Neuritis
Privosegtor is a novel neuroprotective peptoid small-molecule candidate designed to cross both the blood-brain and retinal barriers. The development strategy builds on positive Phase 2 ACUITY trial results in optic neuritis, where the therapy demonstrated improvements in visual function, preservation of retinal ganglion cell integrity, and reduced neurofilament levels, a biomarker of neuroaxonal injury. Because optic neuritis is a common manifestation of multiple sclerosis relapses, Oculis believes the findings provide a strong scientific foundation for expanding development into broader acute MS relapse indications. According to the company, the FDA’s constructive guidance supports this transition without requiring additional preclinical work, potentially accelerating clinical development.
Privosegtor Expands Neuro-Ophthalmology Development Strategy
Despite advances in disease-modifying therapies that reduce relapse frequency in relapsing-remitting multiple sclerosis (RRMS), approximately 170,000 acute MS relapses occur annually in the United States, and recovery is often incomplete. Current treatment relies primarily on high-dose corticosteroids to reduce inflammation, but these therapies do not prevent long-term neuroaxonal damage or disability progression. Oculis aims to position Privosegtor as the first neuroprotective therapy specifically targeting tissue preservation during acute MS relapses. The investigational candidate has already received FDA Breakthrough Therapy, Orphan Drug, and EMA PRIME designations for optic neuritis and is currently being evaluated in the global PIONEER registrational program for optic neuropathies.
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Oculis Expands Neuro-Ophthalmology Pipeline with Regulatory Momentum
The positive FDA pre-IND feedback represents another important regulatory milestone as Oculis continues expanding its neuro-ophthalmology portfolio beyond optic neuritis into broader neurological indications. The company plans to submit the new IND application during the fourth quarter of 2026 and will host a dedicated R&D Day later this year to provide additional updates on both the PIONEER program and the planned acute MS relapse clinical program. By leveraging encouraging Phase 2 clinical data and a streamlined regulatory pathway, Oculis aims to accelerate development of Privosegtor as a potential disease-modifying neuroprotective therapy capable of improving recovery and reducing long-term disability in patients experiencing acute multiple sclerosis relapses.
Source: Oculis press release
