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Xalacom

Phase 3

Glaucoma, Open-Angle | Small molecule | Cardiovascular |Pfizer, Inc.|Last Updated: Feb 21, 2021

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-BlindUNCONTROLLED
Total Trials2
Total Enrollment1,476
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00159653A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With GlaucomaPHASE3 COMPLETED 500Jul 1, 2005Jun 1, 2007Feb 21, 202155 United States, Canada
NCT00150267A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular HypertensionPHASE3 COMPLETED 976Feb 1, 2002 -Nov 5, 200874 Australia, Belgium +10
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Study Endpoints
Primary Endpoints
The mean IOP measurements obtained in the study eye at each time point
Incidence of increase of iris pigmentation
incidence of development in darkening/lengthening/thickening of eyelashes and/or pigmentation of periorbital skin
occurrence of ocular/periorbital adverse events
occurrence of serious adverse events.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
XalacomDRUG -
XalatanDRUG -
TimololDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites55

Inclusion Criteria: * Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening Exclusion Criteria: * Closed/ barely open anterior chamber...

Countries:United StatesCanadaAustraliaBelgiumDenmarkFranceGermanyGreeceIrelandItalyNetherlandsSpainSwedenUnited Kingdom
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