Regenxbio initiates second pivotal trial of gene therapy for wet AMD
Regenxbio has initiated a second phase 3 pivotal trial investigating RGX-314 in patients with wet age-related macular degeneration, according to a press release.
ASCENT is a multicenter, randomized, active-controlled trial investigating the safety and efficacy of subretinal delivery of RGX-314, a potential one-time gene therapy, in two dose arms, 6.4 × 1010 genomic copies per eye and 1.3 × 1011 genomic copies per eye, compared with intravitreal aflibercept.
“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,” Steve Pakola, MD, chief medical officer of Regenxbio, said in the release.
The primary endpoint is noninferiority to aflibercept based on best corrected visual acuity change at 1 year. About 465 patients in the U.S. and Canada will be enrolled in the trial.
Regenxbio plans to submit a biologics license application to the FDA in 2024 based on data from ASCENT and the ongoing ATMOSPHERE trial.
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