Adverum Moves Forward With IND Amendment For ADVM-022 Phase 2 Trial In Wet AMD


Adverum Biotechnologies Inc ADVM received feedback via a Type C meeting written response from the FDA regarding its planned Phase 2 trial of ADVM-022 in wet age-related macular degeneration (wet AMD). 

  • Adverum requested the FDA's feedback to align with the regulatory agency before filing the Investigational New Drug (IND) amendment for the Phase 2 trial. 
  • The trial is designed to evaluate the 2 X 10^11 vg/eye dose, a new, lower 6 X 10^10 vg/eye dose of ADVM-022, and new enhanced prophylactic steroid regimens, including new enhanced prophylactic steroid regimens, local steroids, and a combination of local and systemic steroids.
  • Related: Adverum Outlines Development Plan For ADVM-022 Gene Therapy In Wet AMD.
  • The company expects to complete the IND amendment process to enable the initiation of the Phase 2 trial of ADVM-022 in wet AMD in mid-2022.
  • Patient dosing in the trial to start in Q3 of 2022.
  • Price Action: ADVM shares closed 3.13% higher at $1.32 during after-hours trading on Wednesday.

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