Regenxbio announced that enrollment has been completed in the ATMOSPHERE and ASCENT phase 3 pivotal trials evaluating subretinal surabgene lomparvovec (sura-vec, ABBV-RGX-314) for neovascular (wet) age-related macular degeneration (nAMD). Together, the studies have enrolled over 1,200 participants across more than 200 sites worldwide, representing the largest global gene therapy program for nAMD to date.

ATMOSPHERE, which is being conducted in the United States, compares ABBV-RGX-314 with ranibizumab 0.5 mg (Lucentis; Genentech), while ASCENT, conducted in the US and 13 additional countries, evaluates ABBV-RGX-314 vs aflibercept 2 mg (Eylea; Regeneron). The primary endpoint is noninferiority in change from baseline in best-corrected visual acuity (BCVA) at 54 weeks for ATMOSPHERE and 1 year for ASCENT. Secondary endpoints include safety, central retinal thickness, and supplemental anti-VEGF use.

ABBV-RGX-314 consists of the NAV AAV8 vector, which encodes an antibody fragment designed to inhibit vascular endothelial growth factor (VEGF). In addition to nAMD, ABBV-RGX-314 is being investigated as a potential one-time treatment for diabetic retinopathy and other chronic retinal conditions.

Long-term follow-up from earlier studies suggests ABBV-RGX-314 is well tolerated and maintains stable or improved vision for up to 4 years. Topline results from the pivotal trials in nAMD are expected in late 2026.