REGENXBIO reports stable or improved vision five years after surgery with Sura-vec for wet age-related macular degeneration
REGENXBIO reports stable or improved vision five years after surgery with Sura-vec for wet age-related macular degeneration
The data come from cohorts 3 and 4 of an early-stage study. The published press release does not provide the cohort sizes or detailed results from the five-year follow-up. The company expects primary results from two trials comparing Sura-vec with standard drugs in the fourth quarter of 2026.
In wet age-related macular degeneration, leaky blood vessels grow in the central retina. Fluid and blood escaping from these vessels damage the vision used for reading and recognizing faces. VEGF protein stimulates their growth. Drugs that block VEGF preserve vision but require repeated injections into the eye.
Sura-vec is an investigational gene therapy, so it is administered under the retina during surgery under local anesthesia. The surgeon first removes the clear gel inside the eye and then delivers the treatment. This procedure is usually performed on an outpatient basis. An AAV8 viral vector delivers genetic instructions to retinal cells, enabling them to produce an antibody fragment that blocks VEGF. The aim is to reduce the number of subsequent injections.
In 2024, The Lancet published two-year results from a study involving 42 previously treated patients. Each patient received a single subretinal dose of the treatment, then called RGX-314. In most patients in the higher-dose cohorts, vision remained stable or improved, and additional injections of VEGF-blocking drugs were rarely or never needed. One patient in the highest-dose cohort developed pigmentary changes in the central retina after 12 months, followed by a sharp decline in vision. A link to the treatment was considered possible. Asymptomatic pigmentary changes in the lower peripheral retina were reported more often at higher doses.
The five-year follow-up tests whether the clinical effect persists. In a statement dated July 18, REGENXBIO reports that vision in cohorts 3 and 4 remained stable or improved, while the need for additional injections decreased. The company separately mentions a patient with polypoidal choroidal vasculopathy, a form of the disease involving abnormal blood vessels beneath the retina, whose disease had not responded to VEGF-blocking drugs. It also reports that long-term follow-up identified no new safety signals and that no intraocular inflammation was observed among participants who completed the study. The published press release does not provide the cohort sizes, changes in visual acuity, or injection rates. The result therefore cannot yet be compared quantitatively with standard treatment.
That comparison should come from ATMOSPHERE and ASCENT. In these trials, participants are randomly assigned to receive either Sura-vec or standard drugs, specifically ranibizumab or aflibercept. According to REGENXBIO, the two trials enrolled more than 1 200 people. The company expects primary results in the fourth quarter of 2026. The main question is whether surgery can preserve visual acuity with properly fitted glasses or contact lenses at least as well as regular injections.