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brimonidine/timolol fixed combination

Phase 3

Ocular Hypertension | Small molecule | Cardiovascular |AbbVie Inc.|Last Updated: May 30, 2011

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 Trials3
Total Enrollment1,232
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00332384Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular HypertensionPHASE3 COMPLETED 573Jan 1, 2000Nov 1, 2001May 30, 20111 United States
NCT00332436Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular HypertensionPHASE3 COMPLETED 586Dec 1, 1999Nov 1, 2001May 30, 20111 United States
NCT00332345Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular HypertensionPHASE2 COMPLETED 73Jul 1, 1999Aug 1, 1999May 30, 20111 United States
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Study Endpoints
Primary Endpoints
IOP
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
brimonidine/timolol fixed combinationDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes * Patient requires IOP-lowering drug in both eyes Exclusion Criteria: * Uncontrolled medical conditions * contraindication to beta-adrenoceptor antagonist or brimonidine therapy

Countries:United States
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