REGENXBIO reports three-year ALTITUDE results for sura-vec diabetic retinopathy program
- REGENXBIO (NASDAQ:RGNX) reported three-year Phase II ALTITUDE data for investigational gene therapy sura-vec in non-proliferative diabetic retinopathy.
- At the highest evaluated dose, 60% of participants with three-year follow-up achieved a greater than two-step improvement in diabetic retinopathy severity without additional treatment.
- No intraocular inflammation was observed through three years, and no new sura-vec-related safety signals were identified.
REGENXBIO (NASDAQ:RGNX) announced three-year Phase II results from the ALTITUDE clinical trial evaluating investigational sura-vec for non-proliferative diabetic retinopathy (NPDR).
The company reported results from participants receiving Dose Level 3, which involved a single administration of 1.0×10¹² genome copies per eye.
Among participants with three-year follow-up visits, 60% (6 of 10) achieved a greater than two-step improvement on the Diabetic Retinopathy Severity Scale (DRSS) without requiring additional diabetic retinopathy treatment.
REGENXBIO said all six participants who achieved the improvement had no vision-threatening diabetic retinopathy events during follow-up.
Sura-vec was administered once in an office-based procedure and required a short course of preventive steroid eye drops.
The company reported that no intraocular inflammation was observed through three years among the evaluated safety population (n=17), and no new safety concerns related to sura-vec were identified during long-term monitoring.
The data cutoff for the analysis was August 17, 2026.
