Oculis Announces Positive FDA Pre-IND Feedback Supporting Privosegtor Development Strategy for Treatment of Acute Multiple Sclerosis Relapses

The FDA Division of Neurology provided positive feedback supporting a regulatory pathway for Privosegtor in acute multiple sclerosis (MS) relapses, addressing a significant unmet medical need. The FDA confirmed that existing Privosegtor data can be cross-referenced for a new Investigational New Drug (IND) application in acute MS relapses, planned for submission in the fourth quarter of 2026. Privosegtor, a novel neuroprotective candidate, continues to advance across core neuro-ophthalmology indications, including optic neuropathies and acute MS relapses, and is transforming Oculis as an emerging leader in neuro-ophthalmology. Oculis will host a virtual R&D Day in the fourth quarter of 2026 to provide further updates on its clinical pipeline. Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology, today announced positive U.S. Food and Drug Administration (FDA) pre-IND feedback regarding Privosegtor’s clinical development plan in acute multiple sclerosis (MS) relapses. Privosegtor is a novel peptoid small-molecule candidate with potential neuroprotective properties. In the previously completed Phase 2 ACUITY study, Privosegtor showed a clear neuroprotective effect in optic neuritis, improving visual function, preserving retinal ganglion cell (RGC) layer integrity, and reducing neurofilament levels, a biomarker of axonal injury. Optic neuritis is frequently observed during new onsets of MS or as a typical relapse and serves as a well-established pathophysiological model that is generalizable to potentially all other acute MS relapses. The ACUITY study evaluated a broad population of patients with optic neuritis (ON), including those with and without MS. The ACUITY study provided confidence to investigate Privosegtor in the ongoing PIONEER global registrational program for optic neuritis. Expanding into acute MS relapses is a natural evolution for the Privosegtor program as the Company looks to leverage positive learnings from the ACUITY study and to address additional relapse types. Oculis requested pre-IND feedback from the FDA to guide its development plans with Privosegtor for a potential new indication in acute MS relapses. The FDA Division of Neurology provided guidance that Oculis could cross-reference data from the open IND and that no additional preclinical studies are required for an IND submission in acute MS relapses. The constructive FDA feedback also supported the proposed clinical development strategy and regulatory pathway, which will include MS patients with both optic neuritis and other relapses, such as ambulatory relapses, in future trials. It also supported a primary endpoint as early as 3 months, with the same 3mg/kg dose administered daily for 5 days as in PIONEER-1. Oculis anticipates an IND submission for the treatment of acute MS relapses in the fourth quarter of 2026. Riad Sherif, M.D., Chief Executive Officer of Oculis, remarked: “ Our recent positive engagement with the FDA supports a regulatory pathway for Privosegtor in acute MS relapses, an area of high unmet need with no currently approved neuroprotective options. Building on positive Phase 2 ACUITY data in optic neuritis, a frequent type of MS relapse, we believe Privosegtor has the potential to mitigate neuroaxonal damage and improve recovery following acute relapse events. This milestone significantly advances our strategy to build a leading neuro-ophthalmology pipeline, and we look forward to sharing further details on PIONEER and...