REGENXBIO Presents Positive Long-Term Data for Surabgene Lomparvovec in Wet AMD and Diabetic Retinopathy at American Society of Retina Specialists Annual Meeting
PRNewsWire
Published: Jul 18, 2026, 06:55 PM
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REGENXBIO Inc. (Nasdaq: RGNX ) today announced positive data from long-term follow-up studies of investigational surabgene lomparvovec (sura-vec, ABBV-RGX-314) in wet AMD using subretinal delivery and diabetic retinopathy (DR) using suprachoroidal delivery. These new data were presented at the American Society of Retina Specialists (ASRS) 44 th Annual Meeting in Montreal, Canada.
"Sura-vec continues to demonstrate a durable safety and efficacy profile across multiple routes of administration, reinforcing its potential to preserve vision long-term and change the treatment paradigm for patients with chronic retinal disease," said Steve Pakola, M.D., Chief Medical Officer of REGENXBIO. "These long-term data support the potential for a single treatment to provide lasting disease control while reducing the burdensome need for chronic anti-VEGF injections, which too often leads to undertreatment and subsequent vision loss. We are especially encouraged by the wet AMD five-year data as sura-vec was evaluated in patients with harder-to-treat disease requiring more frequent injections, unlike other studies that have evaluated treatment-naïve patients. The durable efficacy observed through five years supports the potential of sura-vec to treat a significant unmet need in this community."
Participants in Cohorts 3 and 4 of the Phase I/IIa trial received subretinal sura-vec at doses similar to those being studied in the ATMOSPHERE ® and ASCENT ® pivotal trials and demonstrated stable to improved visual acuity and had meaningful reductions in anti-VEGF treatment burden through five years, apart from a polypoidal participant in Cohort 4 with polypoidal choroidal vasculopathy, refractory to anti-VEGF. Real-world outcomes data show that decline is expected long-term on today's standard of care intravitreal treatments. No new safety signals were identified in long-term follow-up, including no intraocular inflammation observed in participants who completed the Phase I/IIa study.
Data from an external control study of sura-vec compared to real-world anti-VEGF intravitreal injections in wet AMD were also presented at ASRS. At one year, vision was preserved for sura-vec participants compared to real-world anti-VEGF external control-matched participants. Participants who received sura-vec also maintained or improved BCVA gains, had less central retinal thickness fluctuation, and received significantly fewer injections.
REGENXBIO expects to announce topline data with AbbVie from the ATMOSPHERE and ASCENT pivotal trials of sura-vec in wet AMD using subretinal delivery in Q4 2026. ATMOSPHERE and ASCENT are multi-center, randomized, active-controlled trials evaluating sura-vec versus ranibizumab and aflibercept, respectively. The primary endpoint is non-inferiority based on change from baseline in BCVA at 54 weeks and one year, respectively. Secondary endpoints include safety and tolerability, change in central retinal thickness (CRT) and need for supplemental anti-VEGF injections in the treatment arms. Together, these pivotal studies have enrolled over 1,200 participants across more than 200 sites.
Source: PRNewsWire
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