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pegaptanib

Phase 3

Macular Degeneration | Small molecule | Ophthalmology |Pfizer, Inc.|Last Updated: May 12, 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-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment151
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00150202Clinical Study Of EYE001 For Wet-Type AMD (Age-Related Macular Degeneration)PHASE3 COMPLETED 90 — — Jul 1, 2004Oct 1, 2006May 7, 200714 Japan
NCT00239928Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular DegenerationPHASE2 COMPLETED 61 — — Sep 1, 2005Nov 1, 2008May 12, 201112 Japan
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Study Endpoints
Primary Endpoints
Visual aquity change from the baseline to 54 weeks after the first treatment is expected to be similar to that seen in the Western studies.
Summary of Adverse Events
Week 54 (initiation of A5751015 study) up to Week 198

Number of subjects with serious and non-serious adverse events: Subjects with ophthalmic adverse events: Subjects with severe adverse events that interferes significantly with subject's usual function: Subjects discontinued due to adverse events: Subjects with dose reduction or temporary discontinuation due to adverse events

Secondary Endpoints
Safety profile of pegaptanib including side effects and lab test from the baseline to 54 weeks after the first treatment. Blood concentration of the drug from the baseline to 54 weeks after the irst treatment.
Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point
Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point
Weeks 54, every 18 weeks from Week 54 up to Week 198
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EYE001EXPERIMENTAL -
Interventions
NameTypeDescription
pegaptanib sodiumDRUG -
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Wet AMD, Visual Acuity from 20/320 to 20/40 Exclusion Criteria: * Diabetic retinopathy, laser coagulation history

Countries:Japan
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Competitive Landscape -Age-Related Macular Degeneration 31 trials
CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV7PHASE3Surabgene Lomparvovec, Ranibizumab Control, ABBV-RGX-314 Dose 1, Aflibercept, Ranibizumab
Ocular Therapeutix IncOCUL3PHASE3OTX-TKI, Aflibercept
4D Molecular Therapeutics, Inc.FDMT3PHASE34D-150 IVT, EYLEA, Aflibercept IVT
Regeneron Pharmaceuticals, Inc.REGN2PHASE3Aflibercept, Pozelimab, Cemdisiran
EyePoint, Inc.EYPT2PHASE3EYP-1901, Aflibercept
Kodiak Sciences, Inc.KOD1PHASE3Tarcocimab tedromer, Tabirafusp tedromer, Aflibercept
Novartis AG Sponsored ADRNVS4PHASE2Iptacopan, FWY003
Outlook Therapeutics, Inc.OTLK1PHASE3bevacizumab
Adverum Biotechnologies, Inc.ADVM4PHASE3Ixo-vec, Aflibercept, ADVM-022
Apellis Pharmaceuticals, Inc.APLS1PHASE2APL-3007, pegcetacoplan
Johnson & JohnsonJNJ1PHASE2JNJ-81201887
Alcon AGALC1PHASE1AR-14034 lower dose, Aflibercept, Sham procedure
Sanofi SA Sponsored ADRSNY1PHASE1SAR402663, Diluent
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