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licaminlimab

Phase 2

Dry Eye Disease | Monoclonal antibody | Ophthalmology |Oculis Holding AG|Trials Updated: May 5, 2026

licaminlimab development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Apr 2001

licaminlimab target and mechanism

Molecular targetTNFα
Target class-Mab (Antibody)
ModalityMonoclonal antibody

Also known as OCS-02

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment282

FDA Designations

No designations recorded

licaminlimab clinical trials

licaminlimab · 2 trials · 2 indications

Phase 2 2
NCT05896670Safety and Efficacy of Licaminlimab Ophthalmic Solution for the Treatment of Dry Eye DiseaseDry Eye Disease
COMPLETED122 Analytics
NCT07548632A Clinical Study Evaluating Licaminlimab for Dry Eye DiseaseDry Eye Disease (DED)
RECRUITING160 Analytics
PHASE2COMPLETED
Safety and Efficacy of Licaminlimab Ophthalmic Solution for the Treatment of Dry Eye Disease
Dry Eye DiseaseUnlock trial analytics
PHASE2RECRUITING
A Clinical Study Evaluating Licaminlimab for Dry Eye Disease
Dry Eye Disease (DED)Unlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in global ocular discomfort severity score at Day 29 in participants with DED and specific TNFR1 genotype
From Day 1 to Day 29

Secondary Endpoints

Change from baseline in global ocular discomfort severity score at Day 29 in all participants with DED (independent of genotype).
Day 1 to Day 29
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Study Design & Arms

Treatment Arms

ArmTypeDescription
licaminlimabEXPERIMENTAL60 mg/mL licaminlimab ophthalmic solution
VehiclePLACEBO_COMPARATORVehicle of licaminlimab ophthalmic solution

Interventions

NameTypeDescription
licaminlimabDRUGophthalmic solution 60 mg/mL Subjects will be randomized to receive licaminlimab eye drops three times daily (TID) for 6 weeks.
vehicle of OCS-02OTHERinert ophthalmic solution vehicle of OCS-02 Subjects will be randomized to receive vehicle eye drops three times daily (TID) for 6 weeks.
Artificial tearsOTHERSubjects who quality after an initial screening were entered into a run-in phase where they received artificial tears to use three times daily (TID) for approximately 14 days.
Artificial Tear Run-inOTHERArtificial tear eye drop run-in three times daily (TID) for approximately 14 days.
Vehicle of licaminlimabOTHERInert ophthalmic solution vehicle of licaminlimab, three times daily (TID) for 29 days.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL

Key Inclusion Criteria: * Physician diagnosis of Dry Eye Disease in the past 6 months * Use of over-the-counter tears * Must agree to genotype testing Key Exclusion Criteria: \- Have a history or presence of any disorder or condition that may, in the opinion of the Investigator, likely interfere ...

Countries:United States
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Competitive Landscape -Dry Eye Disease 8 trials

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Frequently asked questions about licaminlimab

What is licaminlimab used for?

Licaminlimab is being developed for the treatment of dry eye disease, an ophthalmology condition. It is an investigational monoclonal antibody administered as an ophthalmic solution. The drug is currently in Phase 2 clinical development, with two trials conducted in patients with dry eye disease.

What does licaminlimab target?

Licaminlimab targets tumor necrosis factor alpha, or TNFα. It is a monoclonal antibody designed to bind TNFα, a pro-inflammatory cytokine. By targeting TNFα, licaminlimab aims to reduce inflammation associated with dry eye disease. This mechanism is being evaluated in Phase 2 trials.

Who is developing licaminlimab?

Licaminlimab is being developed by Oculis Holding AG, which trades under the ticker OCS. Oculis is a biopharmaceutical company focused on ophthalmology. The company is advancing licaminlimab as an investigational therapy for dry eye disease.

What phase is licaminlimab in?

Licaminlimab is in Phase 2 clinical development. It has not been approved by the FDA and remains investigational. Two Phase 2 trials have been conducted: one completed and one currently recruiting. The drug is being evaluated for dry eye disease.

What clinical trials is licaminlimab in?

Licaminlimab has been studied in two Phase 2 clinical trials. The completed trial, NCT05896670, evaluated the safety and efficacy of licaminlimab ophthalmic solution in dry eye disease with 122 participants. The ongoing trial, NCT07548632, is recruiting 160 participants in the United States to further evaluate licaminlimab for dry eye disease.