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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