PR Newswire·Oct 6, 2025, 7:05 AM ET

REGENXBIO Announces Completion of Enrollment in Pivotal Trials of Subretinal Surabgene Lomparvovec for Wet AMD

REGENXBIO Inc. completed enrollment in the ATMOSPHERE and ASCENT pivotal trials for surabgene lomparvovec (sura-vec), involving over 1,200 participants across more than 200 global sites.
The two randomized, active-controlled trials evaluate subretinal sura-vec versus ranibizumab (ATMOSPHERE) and aflibercept (ASCENT) for treating wet age-related macular degeneration (wet AMD).
Primary endpoints assess non-inferiority based on changes in Best Corrected Visual Acuity at 54 weeks for ATMOSPHERE and one year for ASCENT, with secondary endpoints focusing on safety, central retinal thickness, and injection frequency.
Topline data from the pivotal program is expected in the fourth quarter of 2026.
Earlier-stage trials demonstrated that sura-vec is well tolerated, with durable treatment effects and stable or improved vision observed up to four years.
Sura-vec utilizes the NAV AAV8 vector to deliver an antibody fragment that inhibits the VEGF pathway, aiming to provide a one-time treatment for wet AMD and other retinal conditions.
The therapy seeks to address the significant burden of current standard care, which requires frequent, life-long intraocular anti-VEGF injections.
REGENXBIO is collaborating with AbbVie on sura-vec, which is designated as ABBV-RGX-314.