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
[email protected]
Investor Relations
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Media Relations
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Amber Fennell / David Daley / Sean Leous
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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 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.