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licaminlimab

Phase 2

Dry Eye Disease | Small molecule | Ophthalmology |Oculis Holding AG|Last Updated: May 5, 2026

Target and mechanism

Molecular targetTNFα
Target class-Mab (Antibody)
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment122

FDA Designations

No designations recorded

Clinical trial landscape

licaminlimab · 2 trials · 2 indications

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

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

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

Interventions

NameTypeDescription
Artificial Tear Run-inOTHERArtificial tear eye drop run-in three times daily (TID) for approximately 14 days.
licaminlimabDRUGLicaminlimab eye drops three times daily (TID) for 29 days.
Vehicle of licaminlimabOTHERInert ophthalmic solution vehicle of licaminlimab, three times daily (TID) for 29 days.
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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

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 7 trials

Frequently asked questions about licaminlimab

What is licaminlimab used for?

Licaminlimab is an investigational small molecule being developed for the treatment of Dry Eye Disease (DED). It is administered as an ophthalmic solution and is currently in Phase 2 clinical development. The drug is not yet approved by regulatory authorities and remains under investigation for this condition.

What does licaminlimab target?

Licaminlimab targets TNFα, a cytokine involved in inflammation. By modulating this target, the drug aims to address inflammatory components of Dry Eye Disease. It is classified as an antibody (-mab) modality, though it is described as a small molecule in development for ophthalmic use.

Who is developing licaminlimab?

Licaminlimab is being developed by Oculis Holding AG, a biopharmaceutical company focused on ophthalmology. The company's stock trades under the ticker OCS. Oculis is conducting clinical trials to evaluate the safety and efficacy of licaminlimab for Dry Eye Disease.

What phase is licaminlimab in?

Licaminlimab is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The development program includes both completed and ongoing Phase 2 trials evaluating the drug for Dry Eye Disease, with one trial currently recruiting participants.

What clinical trials is licaminlimab in?

Licaminlimab has two Phase 2 clinical trials. NCT07548632 is a recruiting study evaluating licaminlimab for Dry Eye Disease in the United States, with an enrollment of 160 participants. NCT05896670 is a completed study assessing the safety and efficacy of licaminlimab ophthalmic solution for Dry Eye Disease, with 122 participants.

Is licaminlimab the same as other dry eye treatments?

Licaminlimab is a distinct investigational drug targeting TNFα for Dry Eye Disease. No alternative names for licaminlimab have been reported. It is being studied as an ophthalmic solution and is not yet approved, distinguishing it from marketed therapies for this condition.