RegenxBio announces start of phase 3 trial of gene therapy for wet AMD
A late-stage clinical trial to evaluate the efficacy and safety of subretinal delivery of RGX-314 in patients with wet age-related macular degeneration (wet AMD) is underway, according to RegenxBio Inc.
RGX-314 is being investigated as a potential one-time gene therapy for the treatment of wet AMD.
ASCENT, which is being conducted in partnership with AbbVie, is the second of two phase 3 trials evaluating RGX-314. A Biologics License Application (BLA) is expected to be submitted to the FDA in 2024 based on the ASCENT trials and the ongoing ATMOSPHERE trial.
“The initiation of ASCENT is an important milestone for the pivotal program for subretinal delivery of RGX-314 in patients with wet AMD, and it is the first trial to be started under our partnership with AbbVie,” said Steve Pakola, MD, Chief Medical Officer of RegenxBio in a press release. “ASCENT is designed similarly to our ongoing ATMOSPHERE trial, and key design elements for both pivotal studies are based on the positive long-term data from our dose-escalation Phase 1/2a trial of RGX-314. We look forward to advancing both trials to support our goal of a BLA filing in 2024.”
Read the full press release here.