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Travoprost Intraocular , high elution

Phase 2

Glaucoma Open-angle | Small molecule | Ophthalmology |Glaukos Corporation|Last Updated: Sep 26, 2023

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-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment154
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02754596Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic SolutionPHASE2 COMPLETED 154Mar 29, 2016Jul 21, 2020Sep 26, 20231 United States
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Study Endpoints
Primary Endpoints
IOP (mmHg) Change From Baseline at Week 12
12 weeks

Change from baseline in IOP (measured in mmHg) at week 12. Negative values represent reductions in IOP from baseline.

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Travoprost Intraocular Implant, high elutionEXPERIMENTALThis implant will be surgically implanted and elute travoprost, a prostaglandin.
Travoprost Intraocular Implant, low elutionEXPERIMENTALThis implant will be surgically implanted and elute travoprost, a prostaglandin.
Timolol Maleate Ophthalmic Solution, 0.5%ACTIVE_COMPARATORTimolol, a beta blocker, will be dosed twice daily
Interventions
NameTypeDescription
Travoprost Intraocular Implant, high elutionDRUGSurgical implant placed within the eye to elute travoprost.
Travoprost Intraocular Implant, low elutionDRUGSurgical implant placed within the eye to elute travoprost
Timolol Maleate Ophthalmic Solution, 0.5%DRUGInstillation of one drop of timolol in the study eye twice daily
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Open angle glaucoma Exclusion Criteria: * Uveitic, neovascular, or angle closure glaucoma; or glaucoma associated with vascular disorders. * Functionally significant visual field loss, including severe nerve fiber bundle defects. * Prior glaucoma surgery. * Uncontrolled syst...

Countries:United States
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