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REGENXBIO Presents Positive Initial Data from Phase II AAVIATE® Trial of RGX-314 for the Treatment of Wet AMD Using Suprachoroidal Delivery and Provides Trial Update at Retina Society 54th Annual Scientific Meeting
ROCKVILLE, Md., Oct. 1, 2021 /PRNewswire/ -- Suprachoroidal delivery of RGX-314 well tolerated in 50 patients in Cohorts 1-3 with no drug-related serious
About this update from Regenxbio Inc.
[{"type":"text","content":"ROCKVILLE, Md., Oct. 1, 2021 /PRNewswire/ --\nSuprachoroidal delivery of RGX-314 well tolerated in 50 patients in Cohorts 1-3 with no drug-related serious adverse events Positive initial data from Cohort 1 at six months after one-time treatment of RGX-314 Treatment effect observed with stable visual acuity and retinal thickness Demonstrated meaningful reduction in anti-VEGF treatment burdenPhase II trial expanded to include third dose level of RGX-314 (1x1012 GC/eye) Company to host conference call and webcast on Friday, October 1 at 5:00 p.m. ET, featuring wet AMD Key Opinion Leaders Nikolas London, M.D., and Peter Campochiaro, M.D.REGENXBIO Inc. (Nasdaq: RGNX) today announced initial data from the ongoing Phase II AAVIATE® trial of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD) using in-office suprachoroidal delivery. The data is being presented at the Retina Society 54th Annual Scientific Meeting by Nikolas London, M.D., M.S., F.A.C.S., Partner and Director of Research, Retina Consultants of San Diego, Chief of Ophthalmology, Scripps Memorial Hospital. RGX-314 is a potential best-in-class, one-time gene therapy for the treatment of wet AMD.\n\"We are pleased to share initial data from the Phase II AAVIATE trial, and we are encouraged by the emerging clinical profile of RGX-314 for the treatment of wet AMD using suprachoroidal delivery, a delivery mechanism which we believe could provide access to gene therapy treatment in all settings of patient care,\" said Steve Pakola, M.D., Chief Medical Officer of REGENXBIO. \"The observed stability of visual acuity and retinal thickness in the backdrop of reduced anti-VEGF injections is encouraging at this first dose level. We look forward to further enhancing our understanding of the potential of RGX-314 when delivered to the suprachoroidal space, as we continue to evaluate two higher dose levels in this trial.\"\n\"These are the first data ever reported from a gene therapy delivered to the suprachoroidal space of the eye in a clinical trial,\" said Dr. London. \"The data from patients in Cohort 1 at six months after RGX-314 administration demonstrate the potential benefit of one-time administration of RGX-314 to the suprachoroidal space for the treatment of wet AMD. I look forward to seeing additional data from the AAVIATE trial.\"\nStudy Design and Safety...