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licaminlimab

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment160
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07548632A Clinical Study Evaluating Licaminlimab for Dry Eye DiseasePHASE2 RECRUITING 160Apr 16, 2026Dec 1, 2026May 5, 202610 United States
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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.
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Eligibility Criteria
Age Range18 Years — 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