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REGENXBIO Presents Positive Interim Data from Phase II ALTITUDE™ Trial of RGX-314 for the Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery
- 47% of patients in Cohort 1 treated with RGX-314 demonstrated a ≥2 step improvement from baseline on the ETDRS-DRSS at six months, compared to 0% of
About this update from Regenxbio Inc.
[{"type":"text","content":"- 47% of patients in Cohort 1 treated with RGX-314 demonstrated a ≥2 step improvement from baseline on the ETDRS-DRSS at six months, compared to 0% of patients in observational control; increase from 33% of patients at three months\n - In-office suprachoroidal delivery of RGX-314 continues to be well tolerated in 15 patients in Cohort 1 with no drug-related serious adverse events at six months- No intraocular inflammation observed\n - Cohorts 2 and 3 continue to enroll patients at a dose level of 5x1011 GC/eye\n\n\nROCKVILLE, Md., Feb. 12, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced additional positive interim data from the ongoing Phase II ALTITUDE™ trial of RGX-314 for the treatment of diabetic retinopathy (DR) without center-involved diabetic macular edema (CI-DME) using in-office suprachoroidal delivery. The data is being presented at the Angiogenesis, Exudation, and Degeneration 2022 conference by Michael A. Klufas, M.D., Retina Service, Wills Eye Hospital, Assistant Professor of Ophthalmology, Thomas Jefferson University. RGX-314 is being investigated as a potential one-time gene therapy for the treatment of wet age-related macular degeneration and DR.\n\n \n \n \n \n \n \n\n \n\"We are pleased to see that RGX-314 continues to be well tolerated at six months following a one-time, in-office injection, with nearly 50 percent of patients dosed with RGX-314 in Cohort 1 demonstrating a clinically meaningful improvement from baseline\" said Steve Pakola, M.D., Chief Medical Officer of REGENXBIO. \"We are continuing to enroll patients in Cohorts 2 and 3 and look forward to sharing additional updates from this trial\"\n\"I am encouraged by the clinical improvement of disease severity observed in the ALTITUDE trial of RGX-314,\" said Dr. Klufas. \"Globally, DR is the leading cause of blindness in working-age adults, and these patients are in need of new treatment options. I look forward to the further investigation of RGX-314 as a potentially compelling treatment option for patients with DR.\" \nStudy Design and Safety Update from Phase II ALTITUDE Trial of RGX-314 for the Treatment of DR Using Suprachoroidal Delivery \nALTITUDE is a multi-center, open-label, randomized, controlled dose-escalation trial evaluating the efficacy, safety and tolerability of suprachoroidal delivery of RGX-314 using the SCS Microi...