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VEGF Trap Eye

Phase 2

Macular Degeneration | Small molecule | Ophthalmology |Regeneron Pharmaceuticals, Inc.|Last Updated: Jun 12, 2013

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
UNCONTROLLED
Total Trials1
Total Enrollment157
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00527423Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMDPHASE2 COMPLETED 157Aug 1, 2007Oct 1, 2011Jun 12, 201333 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Adverse Events (AE)
Baseline of this study to Wk 152

Number of participants with AEs summarized by category

Secondary Endpoints
Frequency (Number of Injections)
Baseline of this study to Wk 152
Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values
Baseline of original study to Wk 156
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Study Design & Arms
AllocationNA
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)EXPERIMENTAL -
Interventions
NameTypeDescription
VEGF Trap EyeDRUGIntravitreal injection
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: * Prior participation in VEGF Trap-Eye Phase I and II studies Exclusion Criteria: * Any ocular or systemic adverse events that would preclude participation * Presence of any condition that would jeopardize subject's participation

Countries:United States
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