REGENXBIO completes enrollment in ATMOSPHERE and ASCENT trials of sura-vec in wet AMD

REGENXBIO completed enrollment in its ATMOSPHERE and ASCENT trials that will be evaluating surabgene lomparvovec (sura-vec, ABBV-RGX-314) in wet age-related macular degeneration (wet AMD) using subretinal delivery.

Sura-vec is intended to be a potential 1-time treatment consisting of the NAV AAV8 vector, which encodes an antibody fragment designed to inhibit vascular endothelial growth factor (VEGF).¹ It is intended for the treatment of wet AMD, diabetic retinopathy, and other chronic retinal conditions. Sura-vec inhibits the VEGF pathway by which new, leaky blood vessels grow and contribute to the accumulation of fluid in the retina, as described by the company.¹

The 2 trials will be multi-center, randomized, active-controlled trials designed to support the global regulatory submissions of sura-vec, according to the company. Both studies are to be conducted in the United States.

ATMOSPHERE will be evaluating sura-vec against ranibizumab with a primary endpoint of non-inferiority based on change from baseline in Best Corrected Visual Acuity (BCVA) at 54 weeks, while ASCENT will be evaluating sura-vec versus aflibercept with a primary endpoint of non-inferiority based on change from baseline in BCVA at 1 year. Secondary endpoints in both trials include safety and tolerability, change in central retinal thickness (CRT) and the need for supplemental anti-VEGF injections in the treatment arms. According to the company, the trials have enrolled over 1,200 patients across 200 sites across the United States.¹

Steve Pakola, MD, chief medical officer of REGENXBIO, commented on the trials in a press release from the company,¹ saying, "Completing enrollment in this large, global pivotal program is an exciting milestone in our efforts to deliver sura-vec to patients as the potential first gene therapy for wet AMD. The millions of patients worldwide with wet AMD are in need of a treatment option that can preserve vision, prevent disease progression, and reduce the significant burden of frequent, lifelong eye injections required with today's standard of care.”

Recently, the company announced the initiation of a pivotal phase 2b/3 clinical trial for sura-vec for the treatment of diabetic retinopathy (DR) using suprachoroidal delivery. The trials follow positive 2-year data from the phase 2 ALTITUDE trial.²

The company stated that it expects topline data from the trials to be available in Q4 of 2026.

References:

1. REGENXBIO announces completion of enrollment in pivotal trials of subretinal surabgene lomparvovec for Wet AMD. Published October 6, 2025. Accessed October 8, 2025. https://ir.regenxbio.com/news-releases/news-release-details/regenxbio-announces-completion-enrollment-pivotal-trials

2. Filkins K. REGENXBIO launches phase 2b/3 trial of sura-vec for diabetic retinopathy. Published August 13, 2025. Accessed October 8, 2025. https://www.ophthalmologytimes.com/view/regenxbio-launches-phase-2b-3-trial-of-sura-vec-for-diabetic-retinopathy