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Anecortave Sterile , /mL

Phase 2

Open-angle Glaucoma | Small molecule | Ophthalmology |Alcon Inc.|Last Updated: Nov 28, 2012

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-BlindCONTROLLED
Total Trials3
Total Enrollment376
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00691717Anecortave Acetate Safety in Patients With Open-Angle Glaucoma or Ocular HypertensionPHASE2 COMPLETED 201Jun 1, 2008Sep 1, 2009Nov 28, 20121 United States
NCT00451152Safety and Efficacy of Anecortave Acetate in Patients With Open-Angle GlaucomaPHASE2 COMPLETED 89Mar 1, 2007Jul 1, 2009Nov 28, 20121 United States
NCT00320203Anecortave Acetate in Patients With Open-angle GlaucomaPHASE2 COMPLETED 86Mar 1, 2006Jan 1, 2008Nov 28, 2012 -
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Study Endpoints
Primary Endpoints
Mean Intraocular Pressure at 8 am
Up to 6 months
Mean Intraocular Pressure (IOP)
3 months
Mean change in intraocular pressure at 9 am from baseline
Weeks 2 and 6, Months 2, 3, 4, 5, 6, 7.5, 9, 10.5, and 12
Secondary Endpoints
Percent of Patients Who Remained Rescue Medication-Free at Month 3 (8 am)
Month 3, 8 am
Percent Treatment Failures
3 months
Time to treatment failure
At time point
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
24 mg Anecortave AcetateEXPERIMENTALAnecortave Acetate Sterile Suspension, 30 mg/mL, single depot administration of 0.8 mL in the study eye
48 mg Anecortave AcetateEXPERIMENTALAnecortave Acetate Sterile Suspension, 60 mg/mL, single depot administration of 0.8 mL in the study eye
60 mg Anecortave AcetateEXPERIMENTALAnecortave Acetate Sterile Suspension, 75 mg/mL, single depot administration of 0.8 mL in the study eye
Anecortave Acetate VehiclePLACEBO_COMPARATORSingle depot administration of 0.8 mL in the study eye
Anecortave Acetate DepotEXPERIMENTAL -
Anecortave Acetate 3 mg DepotEXPERIMENTALSingle injection, anterior juxtascleral depot (AJD)
Anecortave Acetate 15 mg DepotEXPERIMENTALSingle injection, anterior juxtascleral depot (AJD)
Anecortave Acetate 30 mg DepotEXPERIMENTALSingle injection, anterior juxtascleral depot (AJD)
Interventions
NameTypeDescription
Anecortave Acetate Sterile Suspension, 30 mg/mLDRUGSingle administration by anterior juxtascleral depot
Anecortave Acetate Sterile Suspension, 60 mg/mLDRUGSingle administration by anterior juxtascleral depot
Anecortave Acetate Sterile Suspension, 75 mg/mLDRUGSingle administration by anterior juxtascleral depot
Anecortave Acetate VehicleOTHERSingle administration by anterior juxtascleral depot
Anecortave Acetate Sterile Suspension, 6 mg/mLDRUGSingle injection, anterior juxtascleral depot (AJD)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients 18 years of age or older with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation) or ocular hypertension. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Patients with any form of glaucoma other than open-angle....

Countries:United States
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Competitive Landscape -Open-Angle Glaucoma 9 trials