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REGENXBIO Announces Enrollment Complete in Cohort 5 of Phase II AAVIATE® Trial
85 subjects dosed across five cohorts in AAVIATE® trial evaluating RGX-314 for the treatment of wet AMD using suprachoroidal deliveryCompany expects to report
About this update from Regenxbio Inc.
[{"type":"text","content":"85 subjects dosed across five cohorts in AAVIATE® trial evaluating RGX-314 for the treatment of wet AMD using suprachoroidal deliveryCompany expects to report additional suprachoroidal data later this yearROCKVILLE, Md., July 8, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it has completed enrollment in Cohort 5 of the Phase II AAVIATE® trial of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD) using in-office suprachoroidal delivery.\n\"We are encouraged by the excellent progress we have made advancing RGX-314 suprachoroidal delivery in both our AAVIATE and ALTITUDE™ trials for the treatment of wet AMD and diabetic retinopathy,\" said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. \"RGX-314, has the potential through delivery to the suprachoroidal space to offer the millions of patients facing vision loss from these retinal diseases with a one-time, in-office treatment option. We plan to present additional suprachoroidal data this year.\"\nResults from Cohort 1 of the Phase II ALTITUDE trial of RGX-314 for the treatment of diabetic retinopathy were presented at the Angiogenesis, Exudation, and Degeneration 2022 conference and will be encored at the upcoming American Society of Retina Specialists Annual Meeting.\nAAVIATE Clinical Trial The multi-center, open-label, randomized, active-controlled, dose-escalation Phase II AAVIATE trial is evaluating the efficacy, safety and tolerability of suprachoroidal delivery of RGX-314 in patients with wet AMD using the Clearside SCS Microinjector®. Twenty patients in Cohort 1 were randomized to receive RGX-314 at a dose level of 2.5x1011 genomic copies per eye (GC/eye) through one injection versus monthly 0.5 mg ranibizumab intravitreal injection at a 3:1 ratio. Twenty patients in Cohort 2 were randomized to receive RGX-314 at a dose level of 5x1011 GC/eye through two injections versus monthly 0.5 mg ranibizumab intravitreal injection at a 3:1 ratio. Cohort 3 is evaluating RGX-314 at the same dose level as Cohort 2 in 20 patients who are neutralizing antibody (NAb) positive. Cohort 4 is evaluating RGX-314 in 15 patients at a dose level of 1x1012 GC/eye and Cohort 5 is evaluating the same dose level of RGX-314 in 20 patients who are NAb positive. Patients in these cohorts did not receive prophylactic immune suppressive cor...