Oculis presents Phase 2 ACUITY trial data on Privosegtor for optic neuritis at NANOS 2026, showing visual acuity improvements.
Quiver AI Summary
Oculis Holding AG announced the presentation of promising Phase 2 data for its neuroprotective therapy, Privosegtor, at the North American Neuro-Ophthalmology Society's annual meeting in Boston. The ACUITY trial demonstrated significant improvements in low-contrast visual acuity and structural preservation of the retina in patients with optic neuritis, suggesting Privosegtor could be the first neuroprotective treatment for this condition. Following its designation as Breakthrough Therapy by the FDA, Oculis is advancing its PIONEER registrational program, which includes trials for optic neuropathies. Oculis, a global biopharmaceutical company dedicated to innovations in ophthalmology, emphasizes its commitment to the field through support of the NANOS congress and the development of Privosegtor, which has shown potential applications beyond optic neuritis.
Potential Positives
- Oculis presented significant Phase 2 trial data on Privosegtor, which shows improvements in low-contrast visual acuity and potential neuroprotective effects for patients with optic neuritis.
- The positive results from the ACUITY trial position Privosegtor as a potential first neuroprotective therapy for optic neuritis, addressing a significant unmet medical need.
- Oculis secured Breakthrough Therapy designation from the FDA for Privosegtor, enhancing its visibility and potential for expedited development and commercialization.
- As a Platinum Sponsor of the NANOS conference, Oculis reinforces its commitment to advancing neuro-ophthalmology and gains exposure among leading experts in the field.
Potential Negatives
- Oculis has not yet received regulatory approval for Privosegtor, meaning that despite potential benefits, the drug remains investigational and cannot be marketed or used commercially at this time.
- The reliance on Phase 2 trial results to garner attention at a major conference may raise concerns about the robustness and readiness of the data, as larger, more conclusive Phase 3 trials are not mentioned.
- The company's emphasis on breakthrough designations and potential future applications may detract from addressing the present backlog of unmet needs and affirming the urgency for eligible patients awaiting effective treatments.
FAQ
What is the ACUITY Phase 2 trial?
The ACUITY Phase 2 trial investigates the effectiveness of Privosegtor in treating optic neuritis.
When will the ACUITY trial results be presented?
The results will be presented on March 23, 2026, at the NANOS Annual Meeting in Boston.
What is Privosegtor?
Privosegtor is a novel peptoid small molecule aimed at providing neuroprotection for optic neuritis and other conditions.
What are the potential benefits of Privosegtor?
Privosegtor may improve visual acuity and protect retinal cells from damage in optic neuritis patients.
What designation has the FDA granted to Privosegtor?
Privosegtor has received Breakthrough Therapy and Orphan Drug designations from the FDA for optic neuritis.
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, 16 March, 2026 -- Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (Oculis), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in ophthalmology and neuro-ophthalmology, today announced the presentation of the ACUITY Phase 2 data with Privosegtor at the North American Neuro-Ophthalmology Society (NANOS) 52nd Annual Meeting.
This premier annual gathering of neuro-ophthalmology experts worldwide provides a scientific forefront platform for presenting transformative clinical data amongst leading clinicians, researchers, and thought leaders.
As a Platinum Sponsor of the 2026 Congress, Oculis is proud to support the most influential global scientific meeting in neuro-ophthalmology, reinforcing its commitment to advancing scientific progress in this field.
NANOS 2026
March 20-24, Boston, MA, USA
"Improved Low-Contrast Visual Acuity and Reduction in Retinal Ganglion Cell Loss with Privosegtor in Acute Optic Neuritis: Results from a Multicenter, Randomized, Placebo-Controlled, Double-Masked Trial".
- Presenter: Professor Martin S. Zinkernagel, M.D., Ph.D., Chair of the Department of Ophthalmology at the University Hospital of Bern, Switzerland
- Date/Time: Monday March 23, 8:48 AM EDT
The presentation of the Phase 2 ACUITY trial results investigating Privosegtor in patients with optic neuritis (ON) will focus on the significant improvements in low contrast visual acuity and promising neuroprotective structural and biological effects observed in the study. Privosegtor, a peptoid small molecule with the ability to cross both the blood brain and retinal barriers, has the potential to become the first neuroprotective therapy for optic neuritis, with broad potential applicability in other neuro-ophthalmic and neurological diseases. Following Breakthrough Therapy designation from the U.S. Food and Drug Administration for ON, Oculis is advancing the PIONEER registrational program for Privosegtor in optic neuropathies, with the PIONEER-1 trial in optic neuritis initiated in Q4 2025.
Riad Sherif, M.D., Chief Executive Officer of Oculis, said “Our commitment to advancing the field of neuro-ophthalmology has never been stronger. The ACUITY Phase 2 results with Privosegtor highlight meaningful progress toward delivering a much-needed neuroprotective therapy to patients with optic neuritis and other optic neuropathies. The opportunity to present the groundbreaking data from this trial at NANOS, recognized as the most important global forum for neuro-ophthalmic science, represents a significant milestone for Oculis and for patients. As a Platinum Sponsor for this year’s congress, we are honored to support and partner with the scientific community in shaping the future of neuroprotective therapies.”
Martin Zinkernagel, M.D., Ph.D., is Professor and Chair of the Department of Ophthalmology at the University Hospital of Bern, Switzerland, as well as director of the internationally renowned Bern Photographic Reading Center at the University of Bern. Professor Zinkernagel is highly recognized in the field with over 270 publications spanning his research interests in retinal imaging, ophthalmic data analysis using artificial intelligence, and the influence of the gut microbiome in retinal disease. He earned his M.D. at the University of Zurich and his PhD in ocular immunology and gene therapy from the University of Western Australia.
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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 diseases. Positive results from the ACUITY Phase 2 trial demonstrated Privosegtor’s neuroprotective potential through anatomical preservation of the retina and improvements in visual function after an acute episode of optic neuritis. Consistent results were observed in animal models of neuroinflammation and neurodegeneration, where Privosegtor preserved retinal ganglion cell damage and was associated with improvements in mobility (clinical function disability). Privosegtor has received Breakthrough Therapy designation from the FDA and Orphan Drug designation from both the FDA and the EMA for ON and is now entering registrational trials for this indication, as well as a registrational trial in non-arteritic anterior ischemic optic neuropathy (NAION), as part of Oculis’ PIONEER (Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research) program. 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 sclerosis 1,2 . 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 includes three core product candidates: Privosegtor, a breakthrough neuroprotective candidate in the PIONEER program which consists of studies intended to support registration plans for treatment in optic neuropathies like optic neuritis (ON) and non-arteritic anterior ischemic optic neuropathy (NAION), with potentially broad clinical applications in various other neuro-ophthalmic and neurological diseases; OCS-01, an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema (DME); and Licaminlimab, a novel, topical anti-TNFα in registrational trial, which is being developed with a genotype-based approach to drive precision medicine in dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, 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
[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, the initiation, timing, progress and results of current and future clinical trials, Oculis’ research and development programs, regulatory and business strategy; and Oculis’ future development plans, 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.
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.
- Weidong Gu et al. (2023) Incidence of Optic Neuritis and the Associated Risk of Multiple Sclerosis for Service Members of U.S. Armed Forces, Military Medicine, vol. 188, March/April 2023
-
Guier CP, Kaur K, Stokkermans TJ. Optic Neuritis. January 2025. StatPearls.
https://www.ncbi.nlm.nih.gov/books/NBK557853