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licaminlimab

Phase 2

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

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment160
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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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07548632studyFirstPostDate: changed
LOWMay 21, 2026NCT07548632NEW_TRIAL: changed
LOWMay 21, 2026NCT07548632NEW_TRIAL: changed