RGX-314 - (ALTITUDE)

Sept. 24, 2026: REGENXBIO (Nasdaq: RGNX) reported positive 3-year follow-up data from the Phase II ALTITUDE study of surabgene lomparvovec (sura-vec, ABBV-RGX-314) in non-proliferative diabetic retinopathy (NPDR), presented at the Retina Society 59th Annual Scientific Meeting.

In Dose Level 3 patients (1.0×10¹² GC/eye) treated once in-office via suprachoroidal delivery with short-course prophylactic topical steroids, 60% of participants with 3-year visits (6/10) achieved a >2-step improvement on the Diabetic Retinopathy Severity Scale (DRSS) without additional diabetic retinopathy treatment. These participants had no vision-threatening events. Among patients who had a 1-step DRSS improvement at 1 year without supplemental anti-VEGF, 3 of 4 later improved to >2-step DRSS improvement by 3 years without additional treatment.

Safety through 3 years (n=17) showed no new sura-vec-related safety signals and no intraocular inflammation with the short-course steroid regimen.

The company said the results were consistent with previously presented 2.5-year Dose Level 3 data. Dose Level 3 is also being evaluated in the Phase IIb/III NAAVIGATE trial in NPDR.