REGENXBIO Inc. reported three-year follow-up data from the Phase II ALTITUDE study of its investigational gene therapy surabgene lomparvovec, also called sura-vec or ABBV-RGX-314, in diabetic retinopathy. The results, for treatment given by suprachoroidal delivery, were presented at the Retina Society's 59th Annual Scientific Meeting in Los Angeles, the company said.
The data, as of Aug. 17, 2026, covered participants with non-proliferative diabetic retinopathy who received a single in-office dose at Dose Level 3 (1.0×10¹² GC/eye) along with short-course prophylactic topical steroids. The company reported a durable efficacy profile at three years with no new sura-vec-related safety signals. Sixty percent of Dose Level 3 participants with three-year visits (n=6/10) reached more than a two-step improvement on the Diabetic Retinopathy Severity Scale without additional treatment for diabetic retinopathy, and those participants had no vision-threatening events.
REGENXBIO said the majority of participants (n=3/4) who had achieved a one-step DRSS improvement at one year without supplemental anti-VEGF injections went on to reach more than a two-step improvement by three years without additional treatment for diabetic retinopathy. No intraocular inflammation was observed through three years (n=17) with the short-course prophylactic topical steroids, it said, and the findings were consistent with previously presented two and a half-year data from the trial.
Steve Pakola, the company's chief medical officer, said the three-year results continued to show improvements in DRSS and a reduction in disease progression, and that their durability strengthened the company's view of sura-vec. Nikolas London of Retina Consultants San Diego, an investigator on the study, said current preventive treatment requires repeat injections, and that the three-year results supported continued study of sura-vec as a one-time, in-office treatment. The company said Dose Level 3 is being evaluated in the Phase IIb/III NAAVIGATE trial of sura-vec in NPDR.
