Business
REGENXBIO Presents Positive Interim Data from and the Expansion of Phase II ALTITUDE® Trial of RGX-314 for the Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery
RGX-314 continues to be well tolerated in 50 patients from Cohorts 1-3 with no drug-related serious adverse events Patients treated with RGX-314 in Cohorts
About this update from Regenxbio Inc.
[{"type":"text","content":"RGX-314 continues to be well tolerated in 50 patients from Cohorts 1-3 with no drug-related serious adverse events Patients treated with RGX-314 in Cohorts 1-3 demonstrated clinically meaningful improvements in disease severity and less disease worsening versus observation control at six months 20% of patients achieved ≥2-step DRSS improvement vs. 10% in control 54% of patients achieved any DRSS improvement vs. 20% in control 0% of patients worsened ≥2 steps vs. 20% in controlNo meaningful differences in safety outcomes at six months for patients who are NAb positivePhase II trial expanded to include higher third dose level, with patients stratified by DRSS levels across cohorts and all receiving short-course prophylactic ocular steroids following RGX-314 administrationROCKVILLE, Md., Nov. 3, 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 were presented at the 55th Annual Retina Society meeting in Pasadena, CA by Lejla Vajzovic, MD, FASRS, Associate Professor of Ophthalmology and Director of Duke Vitreoretinal Fellowship Program, Vitreoretinal Surgery and Disease, Department of Ophthalmology, Duke University School of Medicine. RGX-314 is being investigated as a potential one-time gene therapy for the treatment of wet age-related macular degeneration, DR, and other chronic retinal conditions.\n\"We are pleased with these positive interim results which demonstrate a clinically meaningful improvement in disease severity versus observational control, with more than 50% of patients dosed with RGX-314 in Cohorts 1-3 seeing improvement from baseline in their DRSS scores,\" said Steve Pakola, M.D., Chief Medical Officer of REGENXBIO. \"RGX-314 continues to be well-tolerated across cohorts, and we look forward to the expansion of this trial to further evaluate the potential of RGX-314 for patients with DR.\" \n\"I am encouraged by the positive results observed in the ALTITUDE trial of RGX-314,\" said Dr. Vajzovic. \"A one-time, in-office injection of RGX-314 gene therapy could potentially provide critical improvement in DR severity and reduce the risk of vision threatening complicat...