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REGENXBIO Presents Positive Initial Data from Phase II ALTITUDE™ Trial of RGX-314 for the Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery at American Society of Retina Specialists Annual Meeting
ROCKVILLE, Md., Oct. 9, 2021 /PRNewswire/ -- Suprachoroidal delivery of RGX-314 well tolerated in 15 patients in Cohort 1 with no drug-related serious adverse
About this update from Regenxbio Inc.
[{"type":"text","content":"ROCKVILLE, Md., Oct. 9, 2021 /PRNewswire/ --\nSuprachoroidal delivery of RGX-314 well tolerated in 15 patients in Cohort 1 with no drug-related serious adverse events No intraocular inflammation observed Positive interim data update from Cohort 1 at three months after one-time treatment of RGX-314 33% of patients demonstrated a ≥2 step improvement from baseline on the ETDRS-DRSS compared to 0% of patients in observational controlCohorts 2 and 3 continue to enroll patients at a dose level of 5x1011 GC/eyeREGENXBIO Inc. (Nasdaq: RGNX) today announced initial 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 American Society of Retina Specialists (ASRS) Annual Meeting by Dennis Marcus, M.D., F.A.S.R.S., President, Southeast Retina Center. RGX-314 is a potential one-time gene therapy in clinical development for the treatment of wet age-related macular degeneration and DR.\n\"We are pleased to share initial data from the Phase II ALTITUDE trial, and we are encouraged to see treatment effect particularly at this early time point of three months after the one-time, in-office administration of RGX-314,\" said Steve Pakola, M.D., Chief Medical Officer of REGENXBIO. \"RGX-314 is the first gene therapy in clinical trials for DR using suprachoroidal delivery, and has the potential to provide sustainable, long-term anti-VEGF protein production in the eye for the treatment of DR, which affects approximately eight million people in the United States alone. We look forward to providing additional updates on this trial next year.\"\n\"DR can start in young adulthood and often progresses quickly, leading to vision-threatening complications, including diabetic macular edema (DME) and neovascularization that can lead to vision loss,\" said Dr. Marcus. \"Current treatment options include 'watchful waiting,' treatment requiring repeated anti-VEGF injections, retinal laser or surgical treatment. This first look at the ALTITUDE trial data is promising, as it shows not only clinical improvement in disease severity as measured by the ETDRS-DRSS, but also that this treatment is well tolerated in patients.\" \nStudy Design and Safety Update from Phase II ALTITUDE Trial of ...