Oculis to Present at Upcoming Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting

• Latest findings from the DME AWARE Delphi Study on unmet needs in diabetic macular edema (DME) management highlighting the need for non-invasive therapeutic options to be presented by Baruch Kuppermann, M.D., Ph.D.
• New post-hoc analysis of OCT scans on GCIPL and analysis of responders with improvement of 15 or 30-letter on low-contrast visual acuity (LCVA) from the Phase 2 ACUITY trial with Privosegtor, to be presented by Martin Zinkernagel, M.D., Ph.D.
• Corporate update on Oculis' pipeline and upcoming milestones to be presented by Riad Sherif, M.D., CEO of Oculis at Eyecelerator
  
  

ZUG, Switzerland, May 01, 2026 (GLOBE NEWSWIRE) -- Oculis Holding AG (NASDAQ:OCS) (Oculis), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in ophthalmology and neuro-ophthalmology, today announced that it will be highlighting the transformative potential of its late-stage pipeline, recent development milestones achieved and key areas of unmet medical needs at the Eyecelerator and Association for Research in Vision and Ophthalmology (ARVO) 2026 Annual Meeting.

Riad Sherif, M.D., Chief Executive Officer of Oculis, said, "ARVO 2026 comes at a pivotal moment for Oculis, with strong late-stage momentum across our portfolio designed to redefine treatment paradigms in both ophthalmic and neuro-ophthalmic diseases. Following the last patient visit completed in April for the DIAMOND Phase 3 program, we are fast approaching the pivotal topline results for OCS-01 eye drops in diabetic macular edema, anticipated in June. Furthermore, we continue to advance Privosegtor and Licaminlimab through their respective registrational programs, PIONEER and PREDICT, and believe that our clinical data, recent development progress and regulatory milestones underscore Oculis' potential to deliver transformative therapies for patients with high unmet medical needs."

Chronologically, Oculis presentations will be:

Company Update – Eyecelerator @ ARVO 2026

• Presenter: Riad Sherif, M.D., CEO of Oculis
• Session: Next Generation Retina Therapeutics and Advances in AI Showcase
• Location: Room 405
• Date/Time: Friday, May 1, 2:14 PM MDT

The company presentation will focus on key recent advancements with Oculis' late-stage pipeline, including several regulatory milestones achieved with Privosegtor, the novel neuroprotective candidate in development for optic neuropathies, and last patient visit completed in the Phase 3 DIAMOND program with novel eye drop candidate, OCS-01, for diabetic macular edema, with anticipated topline results in June 2026. 

Unmet needs in DME management: Latest findings from the DME AWARE Delphi Study

• Presenter: Professor Baruch D. Kuppermann, M.D., Ph.D., Roger F. Steinert Professor, Chair of the Department of Ophthalmology, and Director of the Gavin Herbert Eye Institute at the University of California, Irvine
• Presentation number: 1334
• Session: 202 – Diabetic eye disease 1
• Location: Bluebird Ballroom 1B
• Date/Time: Monday, May 4, 12:30 PM MDT
  
  

DME AWARE, sponsored by Oculis, is a global Delphi initiative composed of a steering committee and panel of 25 leading retina and ophthalmology experts. The study is intended to elevate diabetic macular edema (DME) patient care through the development of a global consensus surrounding unmet needs in DME management. Interim results from Surveys 1 and 2 established consensus regarding the need for non-invasive therapeutic options for DME, and the presentation of results from the final third survey will highlight important clinical considerations, including Best Corrected Visual Acuity (BCVA) loss when considering early intervention and definitions of "poor" and "non-response" to treatment.

Reduction in retinal ganglion cell loss with Privosegtor in acute optic neuritis: post-hoc analysis of OCT scans and analysis of responders with improvement of 15 or 30-letter on LCVA

• Presenter: Professor Martin S. Zinkernagel, M.D., Ph.D., Chair of the Department of Ophthalmology at the University Hospital of Bern, Switzerland
• Presentation number: 4227
• Session: 435 – Neurophthalmology
• Location: Mile High 1A
• Date/Time: Wednesday, May 6, 2:45 PM MDT
  
  

The presentation of results from the Phase 2 ACUITY trial investigating Privosegtor in patients with optic neuritis (ON) will focus on the neuroprotective candidate's potential for vision improvement and sparing neurons in optic nerve disease. The presentation will highlight promising neuroprotective structural effects observed in the study on reduction of retinal ganglion cell loss in patients treated with Privosegtor, supported by new post hoc analysis of OCT scans. 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 ON, with broad potential applicability in other neuro-ophthalmic and neurological diseases. Following Breakthrough Therapy designation from the FDA for ON, as well as Priority Medicines (PRIME) designation by the European Medicines Agency for ON, Oculis is advancing the PIONEER registrational program for Privosegtor in optic neuropathies, which commenced with initiation of the PIONEER-1 trial in ON in Q4 2025.

Baruch D. Kuppermann, M.D., Ph.D. is the Steinert Endowed Professor, Chair of the Department of Ophthalmology and Visual Sciences, and Director of the Gavin Herbert Eye Institute at the University of California, Irvine. He serves as the co-director of the Brunson Center for Translational Vision Research at UC Irvine, which is focused on developing new treatments for blinding retinal conditions and also holds a joint appointment with the Department of Biomedical Engineering at UC Irvine. He has published over 300 peer-reviewed articles in the medical literature and over 100 book chapters and is strongly involved in clinical research, having served as Principal Investigator in many trials evaluating new drugs and technologies. He received his Ph.D. in neuroscience at the California Institute of Technology, and his medical degree at the University of Miami. He completed his residency at University of Southern California Doheny Eye Institute and his fellowships in Retina at both St. Joseph's Medical Center in Baltimore under Drs Ronald Michels and Bert Glaser, and at the University of California, San Diego.

Martin S. Zinkernagel, M.D., Ph.D., is Professor and Chair of the Department of Ophthalmology at the University Hospital of Bern, Switzerland, director of the internationally renowned Bern Photographic Reading Center at the University of Bern and General Secretary of EURETINA. Professor Zinkernagel is highly recognized in the field with over 270 publications spanning his main research interests: retinal imaging, ophthalmic data analysis using artificial intelligence, and the influence of the gut microbiome in retinal disease. His main clinical interests are vitreoretinal surgery, medical retina, ocular traumatology, and cataract surgery and his basic science interests are ocular immunology and inflammation. Professor Zinkernagel earned his M.D. at the University of Zurich and his Ph.D. in ocular immunology and gene therapy from the University of Western Australia.

About OCS-01 eye drops and the OPTIREACH^® technology

Leveraging Oculis' proprietary technology, OCS-01 is an OPTIREACH^® formulation of high concentration dexamethasone eye drop. It is being developed as an eye drop to treat the retina to offer a non-invasive treatment alternative for diabetic macular edema (DME). This route of administration enables easy access to treatment in the early stages of the disease and can be used in combination with other therapies in later stages. In contrast, all currently available treatments require invasive delivery methods, such as intravitreal injections or ocular implants, to reach the retina. The OPTIREACH^® solubilizing formulation technology addresses the main limitations of conventional eye drops by improving the solubility of lipophilic drugs, increasing the residence time on the eye surface and thereby, enabling the drug passage from the eye surface to the posterior segment of the eye. Oculis' OCS-01 is being developed with the aim to transform the current treatment paradigm in DME as a non-invasive topical treatment option.

OCS-01 is an investigational drug in Phase 3 that has not received regulatory approval for commercial use in any country.

About Diabetic Macular Edema (DME)

DME is the leading cause of visual loss and legal blindness in patients with diabetes. Currently, it is estimated to affect around 37 million people worldwide and, with the rise of diabetes, the prevalence is expected to increase to 53 million by 2040^1,2. DME is an irreversible and progressive complication of diabetic retinopathy and is related to consistently having high blood sugar levels that damage nerves and blood vessels in the macula, the area of the retina responsible for sharp vision. DME occurs when blood vessels in the retina swell, and then leak, leading to a fluid build-up (edema) into the retina. There remains a significant need for safe, efficacious, and less burdensome treatments for DME 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 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 Priority Medicines (PRIME) designation by the European Medicines Agency (EMA) as well as Orphan Drug 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 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: OCS-01, an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema (DME); 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), and 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. 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 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, the initiation, timing, progress and results of current and future clinical trials, Oculis' research and development programs, regulatory and business strategy; Oculis' future development plans including the potential broad applicability of the Company's product candidates into additional indications; the timing or likelihood of regulatory filings and approvals; statements about market opportunity, and the Company's expected financial position and cash runway, 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:

1. 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.
2. 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
3. Guier CP, Kaur K, Stokkermans TJ. Optic Neuritis. January 2025. StatPearls. https://www.ncbi.nlm.nih.gov/books/NBK557853