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REGENXBIO Reports First Quarter 2021 Financial Results and Operational Highlights News provided by Share this article ROCKVILLE, Md., May 5, 2021 /PRNewswire/ -- Enrollment ongoing in ATMOSPHERE™, the first of two planned pivotal trials for the subretinal delivery of RGX-314 for the treatment of wet AMD Continued progress and expansion of Phase II AAVIATE ® trial of RGX-314 utilizing in-office suprachoroidal delivery for the treatment of wet AMD Began dosing in Phase I/II trial of RGX-121, a one-time gene therapy for MPS II, in pediatric patients over 5 years old Completed dosing in Cohort...

Pivotal Program for RGX-314 for the Treatment of Wet Age-related Macular Degeneration (wet AMD) REGENXBIO announced in January 2021 that it completed an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss the details of a pivotal program to support a Biologics License Application (BLA). REGENXBIO plans to conduct two randomized, well-controlled clinical trials to evaluate the efficacy and safety of RGX-314 in patients with wet AMD, enrolling approximately 700 patients total. REGENXBIO expects to submit a BLA based on these trials in 2024. ATMOSPHERE™, the firs...