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ADVM-022

Phase 2

Neovascular Age-related Macular Degeneration | Gene therapy | Ophthalmology |Adverum Biotechnologies, Inc.|Last Updated: Aug 22, 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
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment69
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05536973Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]PHASE2 ACTIVE NOT_RECRUITING 69 — — Aug 23, 2022Aug 1, 2028Aug 22, 202539 United States, France +1
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Study Endpoints
Primary Endpoints
Incidence of ocular and non-ocular adverse events
Up to Week 52
Severity of ocular and non-ocular adverse events
Up to Week 52
Mean change in best corrected visual acuity (BCVA) from Baseline
Baseline up to Week 52

BCVA measured by Early Treatment Diabetic Retinopathy Study (ETDRS)

Secondary Endpoints
Percentage of participants from Baseline who lose/gain at least 5, 10 or 15 letters in BCVA
Baseline up to 5 years
Mean change in BCVA from Baseline
Baseline up to 5 years
Percentage of participants who are supplemental aflibercept injection-free
Baseline up to 5 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose 1EXPERIMENTALA single intravitreal injection of ADVM-022 2E11 vg/eye
Dose 2EXPERIMENTALA single intravitreal injection of ADVM-022 6E10 vg/eye
Interventions
NameTypeDescription
ADVM-022GENETICA single IVT injection of 2E11 vg/eye ADVM-022 dose in combination with one (1) of four (4) corticosteroid treatment regimens
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites39

Inclusion Criteria: * Male or female participants, ≥ 50 years of age * Willing and able to provide written, signed informed consent for this study * Demonstrated a meaningful response to anti-VEGF therapy * Participants must be under active anti-VEGF treatment for wet AMD and received a minimum of ...

Countries:United StatesFranceUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05536973primaryCompletionDate: changed
LOWMay 24, 2026NCT05536973studyFirstPostDate: changed