Oculis Completes Randomization in PREDICT-1 Registrational Trial of Licaminlimab for TNFR1-Mediated Dry Eye Disease

Two-thirds of enrolled patients carry the TNFR1 variant previously associated with greater treatment response in Phase 2 trials.

Rhea-AI Summary

Oculis (OCS) completed randomization in PREDICT-1, its first registrational trial of Licaminlimab for dry eye disease, with 176 patients enrolled. Two-thirds carry a specific TNFR1 genetic variant previously associated with greater treatment response in Phase 2 trials. Oculis expects topline results around year-end 2026.

The multicenter, double-masked trial compares Licaminlimab with vehicle, the formulation without the active drug. Its primary endpoint measures change from baseline at Day 29 in global ocular discomfort severity among patients with the specified genotype. The same measure in all enrolled patients is a key secondary endpoint; safety is also being assessed. In a prior Phase 2 symptom trial, Licaminlimab produced a statistically significant reduction in ocular discomfort versus vehicle at Day 29, with onset observed as early as Day 14.

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Positive

• Moderate pointPREDICT-1 completed randomization, enrolling 176 patients in Licaminlimab’s first registrational trial.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Oculis expects PREDICT-1 topline results around year-end 2026.
• Moderate pointPrior Phase 2 symptom results showed statistically significant ocular discomfort reduction versus vehicle at Day 29.
• Minor pointGenotype-focused enrollment includes 2/3 of patients carrying the targeted TNFR1 variant.
• Minor pointPrior Phase 2 symptom results showed onset of action as early as Day 14.
• Minor pointPhase 2 trials showed greater clinical response among patients with the specified TNFR1 genotype.

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• None.

Key Figures

Patients enrolled: 176 patients Specified-genotype patients: 2/3 of enrolled patients Topline results timing: Around year-end 2026 +1 more

Patients enrolled

176 patients

PREDICT-1; randomization complete

Specified-genotype patients

2/3 of enrolled patients

Carried the specified TNFR1 genetic variant

Topline results timing

Around year-end 2026

PREDICT-1

Primary endpoint assessment

Day 29

Change from baseline in global ocular discomfort severity score in patients with the specified TNFR1 genotype

Key Terms

double-masked, vehicle-controlled, primary endpoint, biomarker

4 terms

double-masked medical

"randomized, multicenter, double-masked, vehicle-controlled study"

Double-masked describes a clinical study setup where neither the people receiving treatments nor the researchers who administer or assess them know who gets the active therapy versus a placebo or comparison. This reduces conscious or unconscious bias and makes results more reliable for regulators and doctors. For investors, double-masked trials carry more credibility—like a taste test where neither the tasters nor the servers know which sample is which—so positive outcomes and approvals are taken more seriously.

vehicle-controlled medical

"double-masked, vehicle-controlled study"

A vehicle-controlled study compares a drug or therapy against the same formulation without the active ingredient — the “vehicle” is the inactive carrier or delivery medium. Think of testing a recipe by serving two dishes that look and taste the same except one lacks the key ingredient; any difference shows the ingredient’s real effect. Investors watch vehicle-controlled results because they provide a cleaner measure of a treatment’s benefit and safety, shaping regulatory decisions, clinical value, and company valuation.

primary endpoint medical

"The primary endpoint is the change from baseline at Day 29"

The primary endpoint is the single main result a clinical study is designed to measure to decide if a treatment works, like the finish line in a race that tells you who won. Investors care because meeting or missing this goal drives regulatory decisions, future sales expectations and stock value — it turns trial data into a clear yes-or-no signal about a drug’s commercial prospects.

biomarker medical

"a simple, non-invasive genetic biomarker test can identify this patient population"

A biomarker is a measurable indicator found in the body, such as in blood or tissues, that provides information about health, disease, or how the body responds to treatment. For investors, biomarkers can signal the potential success or risk of medical products or therapies, influencing the value of related companies and industry trends. They act like signals or clues that help assess the progress of medical advancements and their market impact.

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High-Responder Target Enrichment: 2/3 of the 176 enrolled patients carry the target TNFR1 genetic variant previously linked to enhanced clinical response in Phase 2 trials

Precision Medicine Approach in a Large Market: Licaminlimab is positioned as a potential first-in-class precision medicine for an estimated 1.5+ million patients in the U.S. with moderate-to-severe TNFR1-mediated dry eye disease (DED)^1-4, addressing a critical unmet need in a historically heterogeneous indication.

Key Milestone on Track: Topline data from this first-ever genotype-guided registrational trial in DED are anticipated around year-end 2026

ZUG, Switzerland, October 19, 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 completion of randomization in the PREDICT-1 (Personalized dRy Eye Disease Investigational Clinical Trial) genotype-based registrational trial of Licaminlimab to drive precision medicine in dry eye disease (DED). Oculis expects to report topline results around year-end 2026.

Riad Sherif, M.D., Chief Executive Officer of Oculis, said, "Completing randomization in such a timeframe with a new modality demonstrates that genotype-driven development is crucial and precision medicine is urgently needed in DED. PREDICT-1 is an important operational milestone as we track toward topline results around year-end 2026. In prior Phase 2 studies, Licaminlimab showed robust improvement across both signs and symptoms of dry eye disease, with an amplified response in patients harboring a specific TNFR1 genotype. Importantly, a simple, non-invasive genetic biomarker test can identify this patient population, supporting the practical application of this precision medicine approach. PREDICT-1 builds directly on that scientific rationale to validate our genotype-guided strategy. If successful, Licaminlimab has the potential to pioneer a first-in-class precision medicine treatment paradigm, delivering targeted relief to a large, underserved patient population with TNFR1-driven disease.^”

Anat Galor, M.D., M.S.P.H., Professor of Ophthalmology, Bascom Palmer Eye Institute, Miami, added: "Dry eye disease is a highly heterogeneous condition, and treatment response can vary considerably between patients. As a result, selecting the right therapy often involves a lengthy trial-and-error process that can lead to patient dissatisfaction and early treatment discontinuation. A precision medicine approach to identify individuals more likely to benefit from a specific therapy could meaningfully advance care for both patients and clinicians. The findings observed in earlier studies of Licaminlimab provide a compelling rationale for the PREDICT-1 trial, and I look forward to seeing whether this targeted approach can advance a more effective treatment paradigm and improve outcomes for patients living with dry eye disease."

PREDICT‑1, the program's first registrational trial, is designed to evaluate the efficacy of Licaminlimab in DED symptoms compared with vehicle in patients carrying a specific TNFR1 genotype, while also assess its effect and safety in the overall study population. Randomization is complete, with 176 patients enrolled in this randomized, multicenter, double-masked, vehicle-controlled study, 2/3 of whom have the specified TNFR1 genotype. The primary endpoint is the change from baseline at Day 29 in the global ocular discomfort severity score in patients with the specified TNFR1 genotype. The same outcome measure will be evaluated in the overall study population as a key secondary endpoint. Oculis expects to report topline results around year-end 2026.

In a prior Phase 2 trial evaluating DED symptoms, patients treated with Licaminlimab experienced a statistically significant reduction in ocular discomfort compared with vehicle at Day 29, with a rapid onset of action observed as early as Day 14.⁵

TNFR1 is a receptor that mediates TNFα-driven inflammation and apoptosis. In phase 2 trials, Licaminlimab has shown greater clinical response, with substantial improvements in signs and symptoms, among patients with a specific TNFR1 genotype. These findings are consistent with the literature suggesting that genetic variation in the TNF/TNFR1 pathway may account for variability in the inflammatory response⁶, and that TNFR1-mediated inflammation may play a key role in ocular surface pathology in DED. A simple biomarker test could identify the relevant genetic variant, potentially helping physicians determine which patients are more likely to benefit from treatment. The PREDICT-1 trial is designed to leverage these findings with the aim to deliver precision medicine to patients with TNFR1-mediated DED.

An estimated 40 million people in the U.S. have DED and about half are formally diagnosed.¹ Among them, approximately 10 million have moderate-to-severe disease requiring active treatment.".^1-2 Current disease management relies heavily on a trial-and-error therapeutic approach, with only ~13% of patients achieving sustained relief⁷, driving an 85–90% discontinuation rate within the first six months⁸ and underscoring the urgent need for targeted, effective therapy. Approximately 13% to 19% of patients with moderate-to-severe DED, representing an estimated 1.3 to 1.9 million individuals, carry the relevant TNFR1 genetic variant and could potentially benefit from Licaminlimab.^1-4 If approved, Licaminlimab has the potential to transform the treatment landscape by shifting from today’s trial-and-error approach to the first precision medicine for TNFR1-mediated DED.

- Ends -

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 has been well-established in inflammatory disorders where the systemic use of TNF-α inhibitors has led to marked improvements in the 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 which 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 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^9,10. 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 which are efficacious, fast-acting and well-tolerated as well as developing targeted therapeutics for specific patient subtypes to improve treatment outcomes for this heterogeneous patient population.

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 (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 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
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 of Licaminlimab to redefine the treatment paradigm in dry eye disease with a precision medicine approach and satisfy an unmet medical need; the initiation, timing, progress and results of current and future clinical trials, including the progress and timing of the PREDICT-1 trial of Licaminlimab and timing of topline results; Oculis’ research and development programs, regulatory and business strategy; expected milestones; and statements about market opportunity and the estimated number of DED patients with the specific TNFR1 genotype, 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. 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 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 exhibit to Oculis’ Form 6-K filed on August 6, 2026 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)   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)   Shettle L, et al. Topical Anti-TNFα Agent Licaminlimab (OCS-02) Relieves Persistent Ocular Discomfort in Severe Dry Eye Disease: A Randomized Phase II Study. Clin Ophthalmol. 2022
      (6)   Curry P. et al. (2022) Do genetics contribute to TNF inhibition response prediction in Psoriatic Arthritis? The Pharmacogenomics Journal.
      (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)   TFOS DEWS II The Ocular Surface 15 (2017)
      (10)   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

FAQ

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When does Oculis expect PREDICT-1 results for Licaminlimab?

Oculis expects topline results around year-end 2026. Randomization is complete, with 176 patients enrolled in the registrational trial.

What is the primary endpoint in Oculis’s PREDICT-1 dry eye trial?

The primary endpoint is the change from baseline at Day 29 in global ocular discomfort severity score among patients carrying the specified TNFR1 genotype. The same measure in the overall study population is a key secondary endpoint.