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GLK-221

Phase 2

Keratoconus | Small molecule | Ophthalmology |Glaukos Corporation|Last Updated: Feb 10, 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_CONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07400952Placebo-controlled Study to Evaluate the Safety and Efficacy of GLK-221 Ophthalmic Solution in Subjects With KeratoconusPHASE2 RECRUITING 100Dec 23, 2025Apr 1, 2027Feb 10, 20261 United States
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Study Endpoints
Primary Endpoints
Mean change from baseline in maximum corneal curvature
16 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GLK-221 Ophthalmic SolutionEXPERIMENTALGLK-221 Ophthalmic Solution administered topically twice daily to both eyes
PlaceboPLACEBO_COMPARATORPlacebo Ophthalmic Solution administered topically twice daily to both eyes
Interventions
NameTypeDescription
GLK-221 Ophthalmic SolutionDRUGGLK-221 Ophthalmic Solution administered twice daily to both eyes
Placebo Ophthalmic SolutionDRUGPlacebo Ophthalmic Solution administered twice daily to both eyes
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Be ≥ 18 and ≤ 55 years of age * Diagnosis of keratoconus in the study eye Exclusion Criteria: * Pregnant, lactating or planning a pregnancy * Currently enrolled, or within 30 days prior to Screening were enrolled, in another investigational drug or device trial

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07400952primaryCompletionDate: changed
LOWMay 24, 2026NCT07400952studyFirstPostDate: changed