Oculis will present on Privosegtor, a potential neuroprotective therapy for optic neuritis, at Clinical Trials at the Summit 2026.
Quiver AI Summary
Oculis Holding AG has announced its participation in the Clinical Trials at the Summit 2026, taking place in Las Vegas on June 12-13, where it will present findings on Privosegtor, a promising peptoid small molecule poised to become the first neuroprotective therapy for optic neuritis. The presentation will be given by Oculis CEO Riad Sherif and will outline the development process of Privosegtor, which has shown positive results in the Phase 2 ACUITY trial and has received Breakthrough Therapy and PRIME designations from regulatory bodies. The ongoing PIONEER registrational program for Privosegtor aims to address significant unmet medical needs in managing optic neuropathies. The company emphasizes its commitment to developing innovative solutions for patients with neuro-ophthalmic diseases and highlights the potential applicability of Privosegtor beyond optic neuritis.
Potential Positives
- Oculis is showcasing its innovative developments at a prominent conference, Clinical Trials at the Summit 2026, which enhances its visibility in the biopharmaceutical community.
- Privosegtor, the company's lead product, demonstrates promise as a potential first neuroprotective therapy for optic neuritis, addressing a significant unmet medical need.
- The company has received several key regulatory designations, including Breakthrough Therapy designation from the FDA and PRIME designation from the EMA, which may facilitate the development and approval process for Privosegtor.
- Encouraging results from the Phase 2 ACUITY trial highlight Privosegtor's neuroprotective effects, bolstering investor confidence and strategic direction for Oculis.
Potential Negatives
- Privosegtor is still an investigational drug and has not received regulatory approval for commercial use in any country, indicating that the company has not yet secured a path to market for its key product.
- The press release contains extensive forward-looking statements, highlighting the inherent uncertainties and risks in the company's future prospects, which could lead to volatility in investor confidence.
- With no specific therapy approved for acute optic neuritis, the press release emphasizes the significant unmet medical needs, which can be seen as a reflection of the challenges the company faces in delivering viable solutions in a competitive market.
FAQ
What is Privosegtor developed by Oculis?
Privosegtor is a novel peptoid small-molecule candidate aimed at treating optic neuritis and other neuro-ophthalmic diseases.
When will Oculis present at Clinical Trials at the Summit 2026?
Oculis will present on June 13, 2026, at 5:52 PM PDT during the Clinical Trials at the Summit.
What is the significance of the PIONEER program for Oculis?
The PIONEER program aims to support the registration of Privosegtor for treating optic neuropathies, including optic neuritis.
What designations has Privosegtor received from regulatory bodies?
Privosegtor has received Breakthrough Therapy designation from the FDA and PRIME designation from the EMA for optic neuritis.
How many people are affected by optic neuritis globally?
Optic neuritis affects up to 8 in 100,000 people worldwide, with over 30,000 annual cases in the U.S.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
ZUG, Switzerland, June 11, 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 an upcoming presentation at Clinical Trials at the Summit 2026, taking place on June 12-13, 2026, in Las Vegas, Nevada.
Oculis is a proud sponsor of Clinical Trials at the Summit 2026, which brings together experts from around the world to discuss ongoing clinical trials and the latest data, all with the goal of achieving advances in vitreoretinal care.
Details of Oculis’ presentation are as follows:
Clinical Trials at the Summit 2026:
-
Privosegtor in Optic Neuritis: From Discovery to PIONEER Registrational Trials
Presenter: Riad Sherif, M.D., Chief Executive Officer
Date/Time: Saturday, June 13, 2026; 5:52 PM PDT
The presentation will highlight the development journey of Privosegtor, a peptoid small molecule that can cross both the blood-brain and retinal barriers and has the potential to become the first neuroprotective therapy for optic neuritis (ON), with potential broad applicability in other neuro-ophthalmic and neurological diseases. Following the successful Phase 2 ACUITY trial and the granting of Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for ON and PRIME (PRIority MEdicines) designation from the European Medicines Agency (EMA), Oculis is advancing the PIONEER registrational program for Privosegtor in optic neuropathies, with the PIONEER-1 trial in optic neuritis.
“Privosegtor is advancing through our PIONEER registrational program, offering the potential to address significant unmet medical needs in optic neuritis and other optic neuropathies where there are currently no approved neuroprotective therapies to prevent visual impairment,” said Riad Sherif, M.D., Chief Executive Officer of Oculis . “Our progress is supported by encouraging Phase 2 ACUITY data and key regulatory milestones, including Breakthrough Therapy and PRIME designations, and an FDA Special Protocol Assessment for PIONEER-1, which we believe support our strategic direction. We look forward to discussing the PIONEER program at Clinical Trials at the Summit as we navigate late-stage development with the aim of delivering potential transformative new options for patients.”
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 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 (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). In addition to its potential neuroprotective effect on the optic nerve, Privosegtor could also have wide applicability in treating other neuro-ophthalmic and neurological indications.
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 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-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 Contacts
Ms. Sylvia Cheung, CFO
[email protected]
Investor Relations
LifeSci Advisors
Corey Davis, Ph.D.
[email protected]
Media Relations
ICR Healthcare
Amber Fennell / David Daley / Sean Leous
[email protected]
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 initiation, timing, progress and results of current and future clinical trials, the potential of Privosegtor to become the first neuroprotective therapy for ON and provide transformative treatment options to patients, as well as its broader potential in other indications, Oculis’ research and development programs, regulatory and business strategy; expected milestones; 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. 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 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.