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Oculis Announces Positive FDA Pre-IND Feedback Supporting Privosegtor Development Strategy for Treatment of Acute Multiple Sclerosis Relapses
ZUG, Switzerland, Aug. 03, 2026 (GLOBE NEWSWIRE) -- 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 this new program at our upcoming R&D event later this year.” Professor Amit Bar-Or, M.D., Chief, Multiple Sclerosis Division, Department of Neurology, Perelman School of Medicine, University of Pennsylvania, added: “I am very encouraged at the prospect of a novel neuroprotective agent such as Privosegtor entering clinical development in acute MS relapses. While immunomodulators are increasingly deployed in practice to reduce the frequency of relapses in MS patients, recovery from an acute event is very rarely complete. The neurodegeneration that occurs during these acute attacks persists after the relapse, leading to an accumulation of disabilities. Privosegtor, as a CNS-penetrant neuroprotective agent, could potentially enhance recovery following relapses and improve long-term outcomes for people with MS.” Oculis management plans to host an R&D Day in the fourth quarter of 2026 to review additional details on the pivotal development program for Privosegtor in acute MS relapses and provide a comprehensive update on the PIONEER program in optic neuropathies. MS is a chronic immune-mediated disease affecting approximately 2.8 million people worldwide, including around 850,000 in the .S. alone.1-3 There are two main types of MS: relapsing-remitting MS (RRMS) and progressive MS. While progressive MS remains a significant unmet medical need, RRMS is the most common type, representing ~85% of patients at initial diagnosis.2 It is currently managed using immunomodulators or disease-modifying therapies (DMTs) that reduce the rate of relapses and therefore related relapse-associated worsening (RAW). However, relapses still persist for many patients, with an estimated 170,000 MS relapses occurring each year in the U.S.4 During an acute relapse, neurologists commonly use a short course of high-dose corticosteroids to reduce inflammation and shorten the episode, as is also standard of care in optic neuritis. However, corticosteroids do not influence the long-term disability, and recovery from relapses is often incomplete, such as in optic neuritis. The tissue damage that occurs during these relapses can contribute to neuroaxonal loss and the accumulation of functional disability over time, underscoring the need for therapies that protect neurons and axons during relapses. There are currently no neuroprotective therapies approved for MS relapses, and there remains an urgent unmet medical need for treatments that can prevent central nervous system damage. Our recent advancements create a robust clinical development roadmap opportunity for Privosegtor built on two distinct pillars:
Privosegtor, a novel peptoid small-molecule candidate that crosses the blood-brain and retinal barriers, has the potential to become the first neuroprotective therapy for optic neuritis (ON) and other neuro-ophthalmic and neurological diseases. Positive results from the ACUITY Phase 2 trial showed Privosegtor’s neuroprotective potential, as evidenced by improvements in visual function, corroborated by anatomical preservation of the retina, including GCIPL and RNFL layers, and reduced neurofilament levels in the blood after an acute episode of optic neuritis. Consistent results were observed in animal models of glaucoma, optic neuritis, and multiple sclerosis (MS), where Privosegtor preserved retinal ganglion cells and was associated with improvements in mobility (clinical function disability) in the MS model. Privosegtor has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) as well as Orphan Drug designation from both the FDA and the EMA for ON. Privosegtor is currently being evaluated in Oculis’ PIONEER (Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research) program, which includes two registrational trials in ON and one registrational trial in non-arteritic anterior ischemic optic neuropathy (NAION). Building on the ACUITY Phase 2 dataset in optic neuritis and constructive FDA pre-IND feedback, Oculis is also planning an IND submission for Privosegtor for the treatment of acute MS relapses. Privosegtor is an investigational drug and has not received regulatory approval for commercial use in any country. About Oculis Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology. Oculis’ highly differentiated late-stage clinical pipeline focuses on two core product candidates. Privosegtor is a breakthrough neuroprotective candidate in the PIONEER program, which consists of studies intended to support registration plans for treatment of optic neuropathies, including optic neuritis (ON) and non-arteritic anterior ischemic optic neuropathy (NAION). Privosegtor also has potential to be developed for additional indications in other neuro-ophthalmic and neurological diseases. Licaminlimab is a novel, topical anti-TNFa in a registrational trial, and is being developed with a genotype-based approach for treating patients with dry eye disease (DED). Headquartered in Switzerland with operations in the U.S., Iceland and Switzerland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors. For more information, please visit: www.oculis.com Oculis Contact Investor Relations Media Relations Cautionary Statement Regarding Forward Looking Statements References:
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