Oculis to Feature Privosegtor’s Neuroprotective Potential and Ongoing PIONEER Program at APOIS Congress and CNS Summit

Privosegtor is enrolling patients in PIONEER-1, while Oculis expects clearance to study acute multiple sclerosis relapses in Q4 2026.

Rhea-AI Summary

Oculis (OCS) announced upcoming presentations on Privosegtor’s neuroprotective potential and its ongoing development program in optic neuritis at two conferences.

Phase 2 ACUITY findings showed improved visual function, retinal anatomical preservation and reduced blood neurofilament levels. The findings supported FDA Breakthrough Therapy and European Medicines Agency PRIME designations for optic neuritis. PIONEER-1 is enrolling acute-onset optic neuritis patients with and without multiple sclerosis. Oculis expects clearance of an investigational new drug application for acute multiple sclerosis relapses in Q4 2026. Presentations are scheduled at APOIS on November 1 and the CNS Summit on November 2 and 3, 2026.

6 points · 0 major

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

Positive

• Moderate pointPhase 2 ACUITY showed improvements in visual function in patients with acute optic neuritis.
• Moderate pointFDA Breakthrough Therapy and EMA PRIME designations were granted for Privosegtor in optic neuritis.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Oculis expects Q4 2026 clearance of an investigational new drug application for acute multiple sclerosis relapses.
• Minor pointRetinal anatomical preservation supported ACUITY’s visual-function findings.
• Minor pointBlood neurofilament levels decreased in the Phase 2 ACUITY trial.
• Minor pointPIONEER-1 is enrolling acute-onset optic neuritis patients with and without multiple sclerosis.

Negative

• None.

Key Figures

Anticipated IND clearance: Q4 2026

Anticipated IND clearance

Q4 2026

For acute multiple sclerosis relapses

Key Terms

peptoid, registrational trial, neurofilament

3 terms

peptoid technical

"a novel peptoid small-molecule candidate"

A peptoid is a synthetic molecule that mimics peptides but whose side chains are attached to the backbone nitrogen (N-substituted glycine oligomer) rather than to the alpha carbon as in natural peptides. That change in backbone placement makes peptoids resistant to many proteases, alters their three-dimensional folding compared with peptides, and allows rapid, modular chemical synthesis for use in research and therapeutic design, although their biological behavior can differ from true peptides because they lack the peptide backbone’s hydrogen-bonding pattern.

registrational trial medical

"It is currently being evaluated in PIONEER-1, a registrational trial"

A registrational trial is the large, definitive clinical study designed to provide the evidence regulators need to decide whether a new drug or medical product can be approved for sale. Think of it as the final exam for a treatment: passing it can unlock widespread market access and potential revenues, while failing it can sharply reduce a product’s commercial prospects and raise investment risk.

neurofilament medical

"reductions in blood neurofilament levels"

A neurofilament is a structural protein that helps give nerve cells their shape and strength and is released into spinal fluid or blood when those cells are damaged; think of it like a building’s steel beam that sheds rust when the structure is harmed. Investors care because measuring neurofilament levels offers a simple, measurable signal of nerve injury used to track disease progression, select patients and show whether a drug is working in clinical trials, which can affect a therapy’s market prospects and risk profile.

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Positive Phase 2 ACUITY trial findings support Privosegtor’s potential to deliver a first-in-class neuroprotective treatment for patients with optic neuritis and beyond

ZUG, Switzerland, October 29^th, 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 and ophthalmology, today announced upcoming presentations highlighting Privosegtor’s neuroprotective potential and its ongoing development in optic neuritis at the 6th Asia-Pacific Ophthalmic Innovation Society Congress and the CNS Summit.

Oculis will sponsor the 6^th Asia-Pacific Ophthalmic Innovation Society Congress, where Riad Sherif, M.D., Chief Executive Officer, will present an overview of Privosegtor and the PIONEER registrational program.

Privosegtor is a novel peptoid small-molecule candidate that crosses the blood-brain and retinal barriers and could become the first neuroprotective therapy for optic neuritis. It is currently being evaluated in PIONEER-1, a registrational trial enrolling patients with acute-onset optic neuritis, including patients with and without multiple sclerosis.

Aaron Tansy, M.D., Vice President, Development Franchise Head, Neurology at Oculis, on behalf of the authors, will present Phase 2 ACUITY data at the CNS Summit on November 2^nd and 3^rd. The ACUITY trial evaluated Privosegtor in patients with acute optic neuritis and showed improvements in visual function, supported by anatomical preservation of the retina and reductions in blood neurofilament levels.

The positive ACUITY findings supported the granting of Breakthrough Therapy designation by the U.S. Food and Drug Administration and PRIority Medicines (PRIME) designation by the European Medicines Agency for Privosegtor in optic neuritis. Oculis is advancing Privosegtor through the PIONEER registrational program in optic neuropathies and, building on the ACUITY dataset and constructive pre-IND feedback from the FDA’s Neurology division, is also anticipating clearance of an IND for the treatment of acute multiple sclerosis relapses in Q4 2026.

Details of Oculis’ presentations are as follows:

6^th Asia-Pacific Ophthalmic Innovation Society (APOIS) 2026 Congress, October 30^th  – November 1^st :

• Session: Next Waves Technologies II

Presenter:  Riad Sherif, M.D., Chief Executive Officer at Oculis
Date/Time: November 1^st, 2026; 10:30 AM -12:30 PM KST
Location: Grand Walkerhill, Seoul, South Korea

CNS Summit, November 1^st to 4^th:

• Abstract title: Improved Low Contrast Visual Acuity, Reduction in Retinal Ganglion Cell Loss, and Neurofilaments-light with Privosegtor in Acute Optic Neuritis: Results from a Multicenter, Randomized, Placebo-Controlled, Double-Masked Trial

Presenter: Aaron Tansy, M.D., Vice President, Development Franchise Head, Neurology at Oculis, on behalf of authors
Date/Time: November 2^nd and 3^rd, from 5:00 to 7:00 PM EDT
Location: Encore Boston Harbor, Everett, MA, USA

- 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 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, where Privosegtor preserved retinal ganglion cells and was associated with improvements in mobility in the multiple sclerosis model. 

Privosegtor has received Breakthrough Therapy designation from the U.S. Food and Drug Administration and Priority Medicines (PRIME) designation from the European Medicines Agency, as well as Orphan Drug designation from both agencies 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. 

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 and non-arteritic anterior ischemic optic neuropathy. 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. 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 

Contacts 

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 / David Daley / Sean Leous 
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 neuroprotective therapy for optic neuritis and other neuro-ophthalmic and neuro-axonal diseases; 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; and the timing or likelihood of regulatory filings and approvals, 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 subject to risks, variability and contingencies, many of which are beyond Oculis’ control. Results from prior clinical trials may not be replicated in later clinical trials. 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. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those expected and/or expressed or implied by such forward-looking statements, 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. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

FAQ

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What did Oculis’s Phase 2 ACUITY trial show for Privosegtor?

ACUITY showed improved visual function, supported by retinal anatomical preservation and reduced blood neurofilament levels in patients with acute optic neuritis. It was a multicenter, randomized, placebo-controlled, double-masked trial, meaning neither participants nor investigators knew treatment assignments.