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Vonaprument

Phase 3

Geographic Atrophy | Small molecule | Other |Annexon, Inc.|Last Updated: May 4, 2026

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-BlindSHAM_CONTROLLEDDMC
Total Trials1
Total Enrollment659
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06510816A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA)PHASE3 ACTIVE NOT_RECRUITING 659 — — Jul 30, 2024Jul 31, 2027May 4, 2026132 United States, Australia +12
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Study Endpoints
Primary Endpoints
Proportion of Participants Experiencing a Best Corrected Visual Acuity (BCVA) ≥15-letter Loss from Baseline Through Month 15 as Assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Any Two Consecutive Visits
Baseline through Month 15
Secondary Endpoints
Time to Confirmed BCVA ≥15-letter Loss
Baseline to Month 15 and Baseline to Month 24
Proportion of Participants Experiencing a Confirmed BCVA ≥15-letter Loss
Baseline through Month 24
Proportion of Participants with Low-luminance BCVA (LLVA) ≥15-letter Loss
Baseline through Month 15 and Baseline through Month 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VonaprumentEXPERIMENTALParticipants will receive vonaprument IVT injections every month during the 24-month treatment period.
Sham GroupSHAM_COMPARATORParticipants will receive Sham IVT injections every month during the 24-month treatment period.
Interventions
NameTypeDescription
VonaprumentDRUGForm: solution for injection; Route of Administration: IVT injection
Sham AdministrationOTHERForm and Route of Administration: to mimic IVT injection (includes placement of the blunt opening of an empty, needleless syringe barrel on the conjunctiva in the inferotemporal quadrant of the eyeball to stimulate the pressure of an injection).
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites132

Inclusion Criteria: * Diagnosis of dry AMD with GA as determined by the Investigator and confirmed by the independent Central Reading Center. Exclusion Criteria: * Geographic atrophy due to other causes than AMD such as Stargardt disease, cone-rod dystrophy, pathologic myopia, or toxic maculopath...

Countries:United StatesAustraliaAustriaCanadaCzechiaFranceGermanyHungaryItalyNetherlandsNew ZealandPolandSpainUnited Kingdom
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Competitive Landscape -Geographic Atrophy 9 trials
CompanyTickerTrialsLead PhaseDrugs
Regeneron Pharmaceuticals, Inc.REGN2PHASE3Pozelimab, Cemdisiran
Belite Bio, Inc. ADRBLTE1PHASE3Tinlarebant
Annexon, Inc.ANNX1PHASE3Vonaprument
Johnson & JohnsonJNJ1PHASE2JNJ-81201887
AbbVie, Inc.ABBV1PHASE1ABBV-6628, SYFOVRE
Sanofi SA Sponsored ADRSNY1PHASE1SAR446597, Sham Comparator
Ocugen IncOCGN1PHASE1OCU410
Apellis Pharmaceuticals, Inc.APLS1 — Pegcetacoplan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06510816primaryCompletionDate: changed
LOWMay 24, 2026NCT06510816studyFirstPostDate: changed