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REGENXBIO Announces Dosing of First Patient in Phase II ALTITUDE™ Trial of RGX-314 for the Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery
-Second Phase II trial to evaluate RGX-314 using the SCS Microinjector® -Initial data from ALTITUDE expected in 2021 ROCKVILLE, Md., Dec. 10, 2020
About this update from Regenxbio Inc.
[{"type":"text","content":"-Second Phase II trial to evaluate RGX-314 using the SCS Microinjector®\n -Initial data from ALTITUDE expected in 2021\n\n\nROCKVILLE, Md., Dec. 10, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that the first patient has been dosed in ALTITUDE, a Phase II trial to evaluate the suprachoroidal delivery of RGX-314 using the SCS Microinjector for the treatment of diabetic retinopathy (DR).\n\"We are pleased to announce the first patient dosed in our ALTITUDE trial, an important milestone as we continue to evaluate the overall clinical profile of RGX-314 for the treatment of chronic retinal conditions. This is our second Phase II trial using the in-office suprachoroidal delivery approach, which may allow physicians to treat patients with diseases like DR earlier in the disease course,\" said Steve Pakola, M.D., Chief Medical Officer of REGENXBIO. \"Long-term treatment with anti-VEGF injections has been shown to significantly reduce disease progression and severity of DR, even in patients who are asymptomatic, as well as prevent vision threatening complications. We believe that one-time treatment with anti-VEGF gene therapy can have a meaningful impact for patients with DR, and we look forward to providing additional updates from this trial next year.\"\n\"The SCS Microinjector is designed to provide targeted delivery of the gene therapy to the suprachoroidal space, with broad distribution to the back of the eye and into the retina through a one-time, in-office procedure, which could be an important alternative to current standard of care,\" said Charles Wykoff, M.D., Ph.D., trial investigator, Retina Specialist and Director of Research with Retina Consultants of Houston. \n\"DR is the most common cause of vision loss among patients with diabetes, with an average age of disease onset between 45-50 years old. Anti-VEGF injections have been approved by the FDA for diabetic retinopathy, but treatment with anti-VEGF agents requires frequent clinic visits and injections. RGX-314 may provide sustainable, long-term anti-VEGF protein production in the eye, which could be a one-time treatment option for working-age adults,\" said Arshad M. Khanani M.D., ...