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Oculis Joins the National Multiple Sclerosis Society’s Campaign to End MS

Oculis expects to seek FDA authorization to study Privosegtor for acute MS relapses in Q4 2026.

(Moderate)

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Oculis (OCS) has joined the National Multiple Sclerosis Society’s Campaign to End MS as its industry partner focusing on vision. The five-year campaign aims to accelerate research and improve access to care for people with multiple sclerosis.

Oculis has launched the PIONEER program, which includes two trials intended to support registration of Privosegtor for optic neuritis. Following positive FDA feedback before its investigational new drug application, Oculis expects to submit an application for treating acute MS relapses in Q4 2026. The company also plans an R&D Day in Q4 to update its pipeline and development programs.

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3 points · 0 major

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It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

0 major · 0 points

Hollow bars mark forward-looking points. How the balance works

Positive

  • Moderate pointPIONEER launched with two trials intended to support Privosegtor registration for optic neuritis.
  • Moderate pointPositive FDA pre-application feedback supports Privosegtor’s development strategy for acute MS relapses.
  • Minor point. Forward-looking: it has not happened yet and may not happen.Investigational new drug application for acute MS relapses is expected in Q4 2026.

Negative

  • None.

Key Terms

optic neuritis, breakthrough therapy designation, orphan drug designation
3 terms
optic neuritis medical
"first neuroprotective therapy for optic neuritis (ON)"
Inflammation of the optic nerve that can cause sudden vision loss, blurring, or eye pain, often like a camera lens fogging or an electrical wire briefly losing connection. It matters to investors because optic neuritis can signal safety issues for drugs or devices, affect regulatory approval, drive legal or clinical costs, and influence demand for treatments and diagnostic services—so reports of cases can move stock prices in healthcare and biotech names.
breakthrough therapy designation regulatory
"received Breakthrough Therapy designation from the U.S. Food and Drug Administration"
A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.
orphan drug designation regulatory
"as well as Orphan Drug designation from both the FDA and the EMA for ON"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

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Oculis and the National Multiple Sclerosis Society’s campaign share a common goal to accelerate breakthroughs in MS research and improve patients’ quality of life

ZUG, Switzerland, October 1, 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, is partnering with the National Multiple Sclerosis Society on its Campaign to End MS, as the industry partner focusing on Vision, officially launching today, on October 1, 2026. This 5-year campaign aims to accelerate research breakthroughs, improve access to care, and create a future where no one lives with the uncertainty of multiple sclerosis (MS). By bringing together people affected by MS, researchers, healthcare leaders, advocates, and supporters, the campaign seeks to translate scientific progress into meaningful advances in treatment and care, while strengthening the resources and support available to the MS community. Oculis’ sponsorship reflects a shared commitment to advancing innovation, addressing unmet needs, and improving the lives of people affected by MS.

As part of the campaign, the National Multiple Sclerosis Society is convening respected MS thought leaders, health industry and corporate leaders, researchers, and healthcare providers across three programs: a CEO Roundtable, Big Bets for Breakthroughs: The MS Research Symposium, and the Campaign to End MS Gala.

Riad Sherif, M.D., Chief Executive Officer of Oculis, said, "Our sponsorship of the National MS Society's Campaign to End MS marks the beginning of what we believe will be a long-term partnership with an organization that has spent 80 years advancing research and care for people living with MS. We share the Society's commitment to accelerating progress for people affected by MS and, through our Privosegtor development program, we are working to advance a much-needed neuroprotective treatment option for patients experiencing optic neuritis and acute MS relapses.”

Oculis is currently developing Privosegtor with the aim to provide the first neuroprotective therapy for optic neuritis (ON), a common MS relapse type and often the first manifestation of MS, with broad potential applicability in other neuro-ophthalmic and neurological diseases. Following the successful Phase 2 ACUITY trial, Oculis launched the PIONEER (Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research) program, which includes two registrational trials in ON. In addition, following positive pre-IND FDA feedback supporting Privosegtor’s development strategy for treating acute MS relapses, Oculis is on track to submit the related IND in the fourth quarter of this year. The Company plans to host an R&D Day in Q4 to provide updates on its pipeline and development programs, including Privosegtor.

- Ends -

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 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 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 MS

MS is a chronic immune-mediated disease affecting approximately 2.8 million people worldwide, including around 850,000 in the U.S. alone.1-3 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 mitigate the long-term disability, and recovery from relapses is often incomplete, such as in optic neuritis. 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.

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

About the National Multiple Sclerosis Society
The National MS Society, founded in 1946, is the global leader of a growing movement dedicated to creating a world free of MS. The Society funds cutting-edge research for a cure, drives change through advocacy and provides programs and services to help people affected by MS live their best lives.
               
Oculis Contact
Ms. Sylvia Cheung, CFO
sylvia.cheung@oculis.com

Investor Relations
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com

Media Relations
ICR Healthcare
Amber Fennell
oculis@icrhealthcare.com

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:

  1. MS National Society
  2. Wallin et al., 2019, The prevalence of MS in the United States: A population-based estimate using health claims data - PubMed
  3. McGinley et al., 2021, Diagnosis and Treatment of Multiple Sclerosis: A Review - PubMed

Multiple sources on relapse rate (ARR) including: Ocrelizumab versus fingolimod after natalizumab cessation in multiple sclerosis: an observational study - PubMed


FAQ

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When does Oculis expect to submit its Privosegtor application for acute MS relapses?

Oculis expects to submit the investigational new drug application in Q4 2026. The planned submission follows positive FDA feedback supporting the candidate’s development strategy for treating acute MS relapses.

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