The FDA granted fast track designation for ADVM-022, a novel gene therapy candidate for the treatment of wet age-related macular degeneration, according to a press release from Adverum Biotechnologies.
ADVM-022 utilizes a proprietary vector capsid carrying an aflibercept coding sequence under the control of a proprietary expression cassette, the release said. The treatment is administered as a single intravitreal injection.
An open-label, multicenter phase 1 dose-escalation trial will assess the safety and tolerability of ADVM-022 in patients with wet AMD who are responsive to anti-VEGF treatment.
“The FDA’s fast track designation is an important recognition of our ADVM-022 gene therapy program,” Leone Patterson, interim president and CEO of Adverum, said in the release. “We look forward to working with the FDA and benefiting from the potential expedited development and regulatory path offered by their fast track program.”