Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ADVM-022 · 2 trials · 2 indications
BCVA measured by Early Treatment Diabetic Retinopathy Study (ETDRS)
| Arm | Type | Description |
|---|---|---|
| Dose 1 | EXPERIMENTAL | A single intravitreal injection of ADVM-022 2E11 vg/eye |
| Dose 2 | EXPERIMENTAL | A single intravitreal injection of ADVM-022 6E10 vg/eye |
| Name | Type | Description |
|---|---|---|
| ADVM-022 | GENETIC | A single IVT injection of 2E11 vg/eye ADVM-022 dose in combination with one (1) of four (4) corticosteroid treatment regimens |
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 ...
ADVM-022 is an investigational gene therapy being developed for wet age-related macular degeneration (AMD) and neovascular age-related macular degeneration (nAMD). It is designed to deliver a gene that produces aflibercept, a protein that blocks vascular endothelial growth factor, to reduce abnormal blood vessel growth and leakage in the eye.
ADVM-022 targets aflibercept, a protein that acts as a vascular endothelial growth factor (VEGF) inhibitor. By delivering the gene for aflibercept, the therapy aims to provide sustained production of this anti-angiogenic protein within the eye to treat neovascular age-related macular degeneration.
ADVM-022 is being developed by Adverum Biotechnologies, Inc., a publicly traded company listed on the Nasdaq under the ticker symbol ADVM. The company is focused on developing gene therapies for serious retinal diseases.
ADVM-022 is currently in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA. A Phase 1 trial has been completed, and a Phase 2 trial, known as LUNA, is active but not recruiting participants.
ADVM-022 has been studied in two clinical trials. The first, NCT03748784, was a Phase 1 study in patients with wet age-related macular degeneration and was completed. The second, NCT05536973, is the Phase 2 LUNA trial in treatment-experienced patients with neovascular age-related macular degeneration, which is active but not recruiting.
ADVM-022 is not the same as aflibercept. ADVM-022 is a gene therapy that encodes for aflibercept, meaning it delivers the genetic instructions for cells to produce the aflibercept protein. Aflibercept itself is an approved biologic drug, while ADVM-022 is an investigational therapy designed to provide long-term delivery of this protein.