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ABP 938

Phase 3

Chorioretinal Vascular Disease | Small molecule | Ophthalmology |Amgen Inc.|Last Updated: Feb 14, 2025

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment49
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05704725A Study to Evaluate ABP 938 and Aflibercept (Eylea®) in Participants With Chorioretinal Vascular Disease (CVD)PHASE3 COMPLETED 49Jan 23, 2023Mar 24, 2023Feb 14, 20254 United States
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Study Endpoints
Primary Endpoints
Percentage of IVT Injections Successfully Administered
Day of IVT injection (study day 1)

A successful injection was defined by whether the retinal specialist administering the IVT injection answered 'yes' to the following question: Did the PFS allow for the safe and effective administration of the prescribed dose? Percentage of successful injections and Clopper-Pearson 95% Confidence Interval is reported.

Secondary Endpoints
Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) in Study Eye
Up to 28 days
Number of Participants With Serious Ocular TEAEs in Study Eye
Up to 28 days
Number of Participants With Non-ocular Serious TEAEs
Up to 28 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABP 938EXPERIMENTALParticipants will be randomized in a ratio of 2:1 to receive either a single IVT injection of ABP 938 in a PFS or a single injection of aflibercept in a PFS.
AfliberceptEXPERIMENTALParticipants will be randomized in a ratio of 2:1 to receive either a single IVT injection of ABP 938 in a PFS or a single injection of aflibercept in a PFS.
Interventions
NameTypeDescription
ABP 938DRUGIVT injection
AfliberceptDRUGIVT injection
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria * Must sign an IRB approved informed consent form before any study-specific procedures are initiated. * Men or women ≥18 years old. * Treatment-naïve or previously treated neovascular age-related macular degeneration, diabetic macular edema, macular edema following retinal vein o...

Countries:United States
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