Oculis to Host In-Person and Virtual R&D Day: Advancing a Differentiated Late-Stage Development Pipeline

Licaminlimab topline results are anticipated around year-end, while Privosegtor IND clearance is anticipated this quarter.

Rhea-AI Summary

Oculis (OCS) will host an in-person and virtual R&D Day on December 8, 2026, covering its late-stage development pipeline. The event will take place at St. Regis New York at 10:00 EST/16:00 CET.

Presentations will cover the PREDICT-1 registrational trial of Licaminlimab in TNFR1-mediated dry eye disease, with topline results anticipated around year-end. Oculis also expects investigational new drug application clearance for Privosegtor this quarter. Discussions will address its development path in acute multiple sclerosis relapse and execution milestones in the PIONEER program for optic neuritis. Specialist physicians will join management, with live questions following the presentations.

2 points · 0 major

PositiveiHow this balance works

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

How the balance worksHow Sentiment works

0 major · 1 point

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

Positive

• Moderate point. Forward-looking: it has not happened yet and may not happen.Licaminlimab’s PREDICT-1 topline results are anticipated around year-end.
• Minor point. Forward-looking: it has not happened yet and may not happen.Privosegtor’s acute multiple sclerosis relapse development path will be discussed, alongside its optic neuritis program.

Negative

• Minor pointPrivosegtor’s investigational new drug application clearance remains pending, with clearance anticipated this quarter.

Key Figures

Target U.S. patient population: 1.5+ million patients PREDICT-1 topline results: Anticipated around year-end

Target U.S. patient population

1.5+ million patients

Estimated moderate-to-severe TNFR1-mediated dry eye disease

PREDICT-1 topline results

Anticipated around year-end

Registrational trial in TNFR1-mediated dry eye disease

Key Terms

tnfr1-mediated, anti-tnfα, pre-ind, registrational trial

4 terms

tnfr1-mediated medical

"PREDICT-1 registrational trial in TNFR1-mediated dry eye disease"

Describes biological effects or signaling that occur when the cell-surface receptor TNFR1 (tumor necrosis factor receptor 1) is activated, usually by binding the cytokine TNF‑α. Activation of TNFR1 triggers specific intracellular pathways—commonly NF‑κB activation, inflammatory gene expression, and in some contexts programmed cell death (apoptosis or necroptosis)—and is distinct from responses mediated by other TNF receptors such as TNFR2.

anti-tnfα medical

"Licaminlimab is an anti-TNFα eye drop candidate"

Anti-TNFα refers to drugs that block the activity of tumor necrosis factor alpha, a protein that drives inflammation in conditions like rheumatoid arthritis and inflammatory bowel disease. For investors, these therapies matter because they represent large, durable drug markets, carry distinct regulatory and safety risks, and face competition from new entrants and lower-cost biosimilars—factors that directly affect revenue, approval timelines, and long-term profitability.

pre-ind regulatory

"Building on previous FDA pre-IND feedback"

"Pre-ind" is short for "pre-indication" and refers to the period before a formal announcement or official signal that a significant change or event is about to happen, such as a company preparing to release important news. For investors, it can signal a time of increased activity or uncertainty, as market participants try to interpret hints and anticipate future developments. Recognizing pre-ind conditions helps investors make more informed decisions ahead of major shifts.

registrational trial medical

"PREDICT-1 registrational trial in TNFR1-mediated dry eye disease"

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.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

ZUG, Switzerland, November 9, 2026 -- Oculis Holding AG (Nasdaq: OCS; XICE: OCS) (“Oculis”), a global biopharmaceutical company focused on breakthrough innovations in neuro-ophthalmology and ophthalmology, today announced that it will host an in-person and virtual R&D Day at St. Regis New York on Tuesday, December 8, 2026, at 10:00 EST/16:00 CET. To register for the event, click here.

The R&D Day will highlight key clinical and strategic developments across Oculis’ late-stage pipeline, including Licaminlimab in dry eye disease (DED) and the expanding development opportunity for Privosegtor across neuro-ophthalmology and neurology, underscoring its significant “pipeline-in-a-product” potential.

The following world-renowned ophthalmology, neuro-ophthalmology and neurology key opinion leaders (KOLs) are confirmed to join Oculis management:

• Christophe Baudouin, MD, PhD, Professor of Ophthalmology, Université Versailles Saint-Quentin, Université Paris Saclay, France
• Jeffrey Bennett, MD, PhD, Professor of Ophthalmology and Neurology, School of Medicine Anschutz, University of Colorado, United States
• Anat Galor, MD, Professor of Ophthalmology at the Bascom Palmer Eye Institute, Miami Miller School of Medicine, United States
• Ludwig Kappos, MD, Emeritus Professor of Neurology at the University of Basel, Switzerland
• Mark Kupersmith, MD, Clinical Professor of Ophthalmology, Neurosurgery, and Neurology at the Icahn School of Medicine at Mount Sinai, United States
• Wolf A. Lagrèze, MD, Professor of Neuro-ophthalmology, Pediatric Ophthalmology, and Strabology at the University of Freiburg, Germany
• Céline Louapre, MD, PhD, Professor of Neurology at Sorbonne University, France
  
  

Agenda Highlights:

• Licaminlimab: Presentations will feature the PREDICT-1 registrational trial in TNFR1-mediated dry eye disease (DED), with topline results anticipated around year-end. Licaminlimab is an anti-TNFα eye drop candidate being developed as a potential first-in-class precision medicine for an estimated 1.5+ million U.S. patients with moderate-to-severe TNFR1-mediated DED^1-4, addressing a critical unmet need in a historically heterogeneous indication.
• Privosegtor: The event will highlight key execution milestones in the PIONEER program for optic neuritis alongside the clinical roadmap for the candidate's inaugural neurological indication. Building on previous FDA pre-IND feedback and anticipated IND clearance this quarter, key opinion leaders in neurology and neuro-ophthalmology will discuss the therapeutic rationale and development path for Privosegtor in acute multiple sclerosis (MS) relapse.

The R&D Day will also provide an opportunity to meet two recent hires, both of whom have deep neurology backgrounds: Chief Scientific Officer Prof. Björn Tackenberg, MD, PhD, and Franchise Head, Neurology, Aaron Tansy, MD.

Live question and answer sessions will follow the formal presentations.

- END -

About Licaminlimab
Licaminlimab is an anti-TNFα eye drop candidate being developed with a single chain antibody fragment (scFv) technology specifically developed to treat ocular inflammatory diseases. The dual anti-inflammatory and anti-necrotic mechanism of action of TNF-α inhibition is well established in inflammatory disorders, where systemic use of TNF-α inhibitors has led to marked improvements in disease management and treatment outcomes. In Phase 2 trials, Licaminlimab has shown a positive treatment effect on both the signs and symptoms of DED and has been well tolerated. In addition, a genetic biomarker has been identified that showed a more pronounced treatment effect with Licaminlimab in patients with a specific TNFR1 genotype. If approved, Licaminlimab has the potential to transform the treatment paradigm with a precision medicine approach.

Licaminlimab is an investigational drug in a registrational trial and has not received regulatory approval for commercial use in any country.

About Dry Eye Disease (DED)
DED is a multifactorial disease in which ocular surface inflammation plays a central role in sustaining the pathological state^5,6. It usually affects both eyes, and patients may experience a stinging, burning, or scratchy sensation. In addition, some patients experience sensitivity to light, eye redness, difficulty wearing contact lenses, difficulty with nighttime driving, and blurred vision, which can greatly affect their quality of life.

It is a common condition estimated to impact more than 110 million people in the G7 countries (U.S., U.K., Germany, France, Spain, Italy, Japan).¹ Of the approximately 20 million patients who are diagnosed with DED in the U.S., about half, or 10 million, are considered to have moderate to severe disease.^1,2 However, only 13% of DED patients receive prescription treatment, primarily with anti-inflammatory medications¹ , and despite available therapies, most patients (87%) don’t feel that their chronic DED is well-managed⁷ , which highlights a high level of dissatisfaction. Furthermore, 90% of patients discontinued their treatment altogether within one year with the vast majority discontinuing in the first 6 months.⁸ Unmet medical needs remain for novel anti-inflammatory treatments that are efficacious, fast-acting, and well-tolerated, as well as for developing targeted therapeutics for specific patient subtypes to improve treatment outcomes for this heterogeneous patient population.

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 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.^9,10 It mainly occurs in adults between 20 and 40 years of age and is more frequent in women (2:1).¹¹ 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 need remains for therapies that can prevent vision loss after an acute episode by reducing permanent nerve cell damage or death.

About Acute Multiple Sclerosis (MS) Relapses
MS is a chronic immune-mediated disease affecting approximately 2.8 million people worldwide, including around 850,000 in the U.S. alone.^12-14 There are two main types of MS: relapsing-remitting MS (RRMS) and progressive MS. While progressive MS remains a significant unmet medical need, RRMS is the most common type, representing ~85% of patients at initial diagnosis.¹² It is currently managed using immunomodulators or disease-modifying therapies (DMTs) that reduce the rate of relapses and therefore related relapse-associated worsening (RAW). However, relapses still persist for many patients, with an estimated 170,000 MS relapses occurring each year in the U.S.¹⁵

During an acute relapse, neurologists commonly use a short course of high-dose corticosteroids to reduce inflammation and shorten the episode, as is also standard of care in optic neuritis. However, corticosteroids do not influence the long-term disability, and recovery from relapses is often incomplete, such as in optic neuritis. The tissue damage that occurs during these relapses can contribute to neuroaxonal loss and the accumulation of functional disability over time, underscoring the need for therapies that protect neurons and axons during relapses. There are currently no neuroprotective therapies approved for MS relapses, and there remains an urgent unmet medical need for treatments that can prevent central nervous system damage.

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 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 and the potential for Licaminlimab to transform the treatment paradigm in dry eye disease with a precision medicine approach; the initiation, enrollment, 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 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.

References:

1. Jain H, et al. (2020): Dry eye disease landscape and forecast. Decision Resources Group (DRG). Prevalence for G7 countries: France, Germany, Italy, Japan, Spain, UK, and US.
2. GlobalData – Dry Eye Syndrome Global Drug Forecast and Market Analysis to 2026
3.  Galor, A., et al. Licaminlimab in the treatment of dry eye disease: Results from Phase 2 evaluations. Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.
4. Acuna, Kelly & al. (2023). Impact of Tumor Necrosis Factor Receptor 1 (TNFR1) Polymorphism on Dry Eye Disease. Biomolecules.
5. TFOS DEWS II The Ocular Surface 15 (2017)
6. Baudouin C. Dry Eye Disease, the complex interactions of vicious cycles. EuDES European Dry Eye Society https://www.dryeye-society.com/resources/dry-eye-disease-complex-interactions-vicious-cycles
7. Mukamal, R. Why is Dry Eye So Difficult to Treat? 2021 https://www.aao.org/eye-health/tips-prevention/fix-dry-eye-treatment-eyedrops
8. Mbagwu M. et al.: Characterization of Discontinuation and Switching Patterns of DED Medications Using Linked HER Registry and Claims Data. Presented at ASCRS Annual Meeting 2024.
9. Weidong Gu et al. 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
10. Abbass, N.J., Shaia, J.K., Shukla, P. et al. Prevalence of pediatric and adult optic neuritis in the United States from 2016 to 2023. Eye 39, 1608–1614 (2025).
11. Guier CP, Kaur K, Stokkermans TJ. Optic Neuritis. January 2025
12. MS National Society
13. Wallin et al., 2019, The prevalence of MS in the United States: A population-based estimate using health claims data – PubMed
14. McGinley et al., 2021, Diagnosis and Treatment of Multiple Sclerosis: A Review – PubMed
15. Multiple sources on relapse rate (ARR) including: Ocrelizumab versus fingolimod after natalizumab cessation in multiple sclerosis: an observational study – PubMed
    
    

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When and where is Oculis holding its R&D Day?

Oculis will hold its in-person and virtual R&D Day on December 8, 2026, at St. Regis New York, beginning at 10:00 EST/16:00 CET.

When are Oculis PREDICT-1 topline results expected?

Oculis anticipates PREDICT-1 topline results around year-end. The registrational trial evaluates Licaminlimab in TNFR1-mediated dry eye disease and will feature in the R&D Day presentations.