Business
REGENXBIO Announces Pivotal Program for Surabgene Lomparvovec in Diabetic Retinopathy
A pivotal Phase IIb/III clinical trial using suprachoroidal delivery for treatment of diabetic retinopathy will be initiatedNew Phase II ALTITUDE® trial data
About this update from Regenxbio Inc.
[{"type":"text","content":"A pivotal Phase IIb/III clinical trial using suprachoroidal delivery for treatment of diabetic retinopathy will be initiatedNew Phase II ALTITUDE® trial data demonstrate a durable safety and efficacy profile observed through two years with a single, in-office injection of surabgene lomparvovec in subjects with non-proliferative diabetic retinopathyREGENXBIO to receive $100 million upon first subject dosed in the Phase IIb/III clinical trial and an additional $100 million upon first subject dosed in a second Phase III clinical trial ROCKVILLE, Md., Aug. 7, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will initiate a pivotal Phase IIb/III clinical trial for investigational surabgene lomparvovec (sura-vec, ABBV-RGX-314) in diabetic retinopathy (DR) using suprachoroidal delivery and a corresponding amendment to its eyecare collaboration with AbbVie.\nThis clinical advancement follows new, positive two-year data from the Phase II ALTITUDE® trial and long-term follow-up study, which enables the initiation of a global clinical program for DR.\n\"Advancing our DR program to late-stage development brings sura-vec closer to being a potentially transformative new treatment for the millions of people living with DR,\" said Steve Pakola, M.D., Chief Medical Officer, REGENXBIO. \"We remain committed to advancing this program to maximize its value and impact for patients worldwide.\"\n\"DR is a progressive disease, with most patients eventually developing vision threatening events (VTEs) and is the leading cause of blindness among working age adults,\" said Primal Kaur, M.D., Senior Vice President, Global Development of Immunology, Neuroscience, Eye Care and Specialty, AbbVie. \"We are excited to advance this clinical development program with the goal of helping to address these unmet needs and bring an additional option to patients living with DR.\"\nPhase II / Long-Term Follow-Up Clinical Data and Pivotal Program Update* In the Phase II ALTITUDE trial, sura-vec was well tolerated in subjects with non-proliferative diabetic retinopathy (NPDR) at dose levels 1, 2, and 3. As of June 9, 2025, there were no drug-related serious adverse events. No intraocular inflammation was observed through two years at dose level 3 (1.0x1012 GC/eye) (n = 15) with short-course topical prophylactic steroids.\nUpdated Phase II ALTITUDE res...