Oculis to Present Late-Breaking Phase 2 ACUITY Biomarker Analyses of Privosegtor in Optic Neuritis at the 10th Joint ACTRIMS-ECTRIMS Meeting
Presentation highlights new translational data evaluating plasma NfL and GFAP as biomarkers of neuroaxonal injury and neuroinflammation
ZUG, Switzerland, October 20, 2026 -- Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis”), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology, today announced that new biomarker data from the Phase 2 ACUITY trial of Privosegtor will be featured in a late-breaking session at the 10th Joint ACTRIMS-ECTRIMS Meeting (MSToronto 2026), on October 21-23, 2026, in Toronto, Canada.
The presentation will unveil new analyses evaluating circulating neuroaxonal and neuroinflammatory biomarkers, specifically plasma neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP), in patients with acute optic neuritis (ON). These translational endpoints provide critical insight into acute central nervous system injury cascades and the biological rationale underlying neuroprotection.
The presentation will provide congress attendees, clinical investigators, members of the neuro-ophthalmology and multiple sclerosis communities with an opportunity to hear directly from Professor Céline Louapre, the principal investigator of the ACUITY Phase 2 trial, and discuss the new findings during the session.
Details of Oculis' presentation at the ACTRIMS-ECTRIMS joint meeting are as follows:
Presentation: Effect of Privosegtor on Plasma Neurofilament-Light and Glial Fibrillary Acidic Protein Levels in the Phase 2 ACUITY Trial in Optic Neuritis
Presenter: Céline Louapre, M.D., Ph.D., Pitié-Salpêtrière Hospital
Session: Late Breaking Abstracts
Presentation ID: P1507
Date/Time: Thursday, October 22, 2026; 4:30 - 6:30 p.m. EDT
Location: Metro Toronto Convention Centre
“Optic neuritis and demyelinating relapses represent a high-stakes clinical race against permanent neuro-axonal loss and irreversible functional deficits such as visual impairments,” said Riad Sherif, M.D., Chief Executive Officer of Oculis. “With no approved neuroprotective therapies currently available to protect retinal ganglion cells and their axons, which transmit visual signals from the eye to the brain, deep translational analyses are vital to advancing care. At ECTRIMS, Professor Céline Louapre will present objective plasma biomarker readouts from the Phase 2 ACUITY trial, offering key insights into the biological pathways of optic neuritis and the neuroprotective potential of Privosegtor. We invite the international clinical and scientific community to join us for this late-breaking presentation as we work to advance the next frontier of neuroprotection.”
Following the successful Phase 2 ACUITY trial, Privosegtor was granted Breakthrough Therapy designation from the FDA and Priority Medicines (PRIME) designation from the EMA. Oculis’ PIONEER (Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research) program includes two registrational trials evaluating Privosegtor in patients with optic neuritis. The first trial, PIONEER-1, is currently enrolling patients with acute-onset ON across a broad population, including individuals with and without multiple sclerosis. Oculis plans to file an IND for Privosegtor in acute MS relapses. The Company will host an R&D Day on December 8, 2026, to provide updates on its differentiated late-stage pipeline, including Privosegtor and Licaminlimab.
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About Privosegtor
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 neuro-axonal diseases. Positive results from the ACUITY Phase 2 trial showed Privosegtor’s neuroprotective potential, as evidenced by improved visual function, corroborated by anatomical preservation of the retina, including the 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 ON 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 Optic Neuritis
Optic Neuritis (ON) is a rare condition characterized by an acute inflammation of the optic nerve that can lead to permanent visual impairment. It affects up to 8 in 100,000 people worldwide with a U.S. annual incidence estimated to be >30,000 and often represents the first sign of multiple sclerosis1,2. It mainly occurs in adults between the age of 20 and 40 years and is more frequent in women (2:1)3. ON is a type of neuropathy (nerve disease) that happens when acute inflammation of the optic nerve affects the signals traveling from the eyes through the brain, causing pain, vision loss and other symptoms. The cells that make up the optic nerve have a lipid protective coating called a myelin sheath, which is preferentially damaged in ON. Without myelin, the optic nerve cells can’t send signals properly and axons can be irreversibly lost. To date there is no specific therapy approved for acute optic neuritis and the unmet needs remain for therapies that can prevent vision loss after an acute episode by reducing nerve cell permanent damage or death.
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. 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 neuro-axonal diseases. Licaminlimab is a novel, topical anti-TNFα 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
Ms. Sylvia Cheung, CFO
sylvia.cheung@oculis.com
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Cautionary Statement Regarding Forward Looking Statements
This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company’s product candidates, including the potential for Privosegtor to become the first neuroprotection therapy for optic neuritis and its potential broad applicability across neurology, including in acute MS relapses, the initiation, enrollment, timing, progress and results of current and future clinical trials, Oculis’ research and development programs, regulatory and business strategy; Oculis’ future development plans; the timing or likelihood of regulatory filings and approvals; and statements about market opportunity, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Results of earlier stage clinical trials may not be replicated in subsequent clinical trials. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the U.S. Securities and Exchange Commission (SEC). Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
References:
- Martínez-Lapiscina EH, et al. (2014): Is the incidence of optic neuritis rising? Evidence from an epidemiological study in Barcelona (Spain) 2008-2012. J Neurol. 2014 Apr; 261(4): 759-767.
- Pérez-Cambrodí RJ, Gómez-Hurtado Cubillana A, Merino-Suárez ML, Piñero-Llorens DP, Laria-Ochaita C. Optic neuritis in pediatric population: a review in current tendencies of diagnosis and management. J Optom. 2014 Jul-Sep;7(3):125-30.
- Sing Hayreh S. (2008): Nonarteritic anterior ischemic optic neuropathy: natural history of visual outcome. Ophthalmology. 2088 Feb;115(2):298-305.