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AL-39324

Phase 2

Age Related Macular Degeneration | Small molecule | Ophthalmology |Alcon Inc.|Last Updated: Jul 18, 2014

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 Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00992563WALTZ - Wet Age-Related Macular Degeneration (AMD) AL-39324 Treatment ExaminationPHASE2 COMPLETED 35Jun 1, 2010May 1, 2011Jul 18, 2014 -
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Study Endpoints
Primary Endpoints
Incidence of targeted adverse events occurring in the study eye
Up to Day 7 after injection
Secondary Endpoints
Mean change from baseline in central foveal thickness (CFT) at Month 1
Baseline (Day 0), Month 1
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AL-39324 Concentration Level AEXPERIMENTALAL-39324 ophthalmic suspension, single intravitreal injection
AL-39324 Concentration Level BEXPERIMENTALAL-39324 ophthalmic suspension, single intravitreal injection
AL-39324 Concentration Level CEXPERIMENTALAL-39324 ophthalmic suspension, single intravitreal injection
AL-39324 Concentration Level DEXPERIMENTALAL-39324 ophthalmic suspension, single intravitreal injection
AL-39324 Concentration Level EEXPERIMENTALAL-39324 ophthalmic suspension, single intravitreal injection
LucentisACTIVE_COMPARATORRanibizumab 10 mg/mL solution, single intravitreal injection
Interventions
NameTypeDescription
AL-39324 ophthalmic suspensionDRUG -
Ranibizumab 10 mg/mLDRUG -
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Willing to give written informed consent, make the required study visits and follow instructions; * The study eye: * must have a primary diagnosis of choroidal neovascularization (CNV) secondary to AMD; * lesion must be no larger than 30 mm2; * must have edema measuring...

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