REGENXBIO Presents Positive Long-Term Data for Surabgene Lomparvovec in Wet AMD and Diabetic Retinopathy at American Society of Retina Specialists Annual Meeting
REGENXBIO Inc. has reported positive long-term data from follow-up studies of its investigational gene therapy, surabgene lomparvovec (sura-vec, ABBV-RGX-314), in patients with wet age-related macular degeneration (AMD) and diabetic retinopathy (DR). The data were presented at the American Society of Retina Specialists (ASRS) 44th Annual Meeting in Montreal, Canada.
In the studies, one-time treatment with sura-vec demonstrated stable to improved vision through five years in wet AMD patients who previously required frequent anti-VEGF injections. The company noted that no drug-related intraocular inflammation (IOI) was observed in patients who did not receive prophylactic steroids. Additionally, participants with non-proliferative diabetic retinopathy (NPDR) showed a significant reduction in vision-threatening events and an improvement of more than two steps on the Diabetic Retinopathy Severity Scale (DRSS) after 2.5 years, again with no IOI reported when these participants received short-course prophylactic steroids.
Steve Pakola, M.D., Chief Medical Officer of REGENXBIO, stated that the results reinforce the potential of sura-vec to provide long-term disease control, potentially transforming the treatment approach for chronic retinal diseases. He highlighted the durability of the five-year data, especially in patients who required frequent injections, contrasting them with other studies involving treatment-naïve patients.
Topline data from ongoing pivotal studies of sura-vec in wet AMD, known as ATMOSPHERE and ASCENT, are expected to be released in the fourth quarter of 2026. These multi-center trials are investigating sura-vec against standard therapies and have enrolled over 1,200 participants across more than 200 sites.
In the Phase II ALTITUDE trial, results showed that a single administration of sura-vec for NPDR demonstrated a durable safety and efficacy profile, with more than half of participants achieving at least a two-step improvement on the DRSS. As of May 25, 2026, there were no reported cases of intraocular inflammation within the group treated with short-course prophylactic steroids.