REGENXBIO's Gene Therapy Shows 3-Year Durability in Diabetic Retinopathy Trial
Event summary
- 60% of Dose Level 3 participants in REGENXBIO's Phase II ALTITUDE trial achieved >2-step improvement on the Diabetic Retinopathy Severity Scale (DRSS) at three years post-treatment with surabgene lomparvovec.
- No new sura-vec-related safety signals or intraocular inflammation observed through three years with short-course prophylactic topical steroids.
- Data presented at the Retina Society 59th Annual Scientific Meeting on September 24, 2026.
- Dose Level 3 is being evaluated in the Phase IIb/III NAAVIGATE trial for non-proliferative diabetic retinopathy (NPDR).
The big picture
REGENXBIO's positive three-year data for surabgene lomparvovec reinforces the potential of gene therapy to transform diabetic retinopathy treatment. The durability of results without additional treatments or safety concerns positions sura-vec as a potential game-changer in a market dominated by repetitive anti-VEGF injections. The success of this program could validate REGENXBIO's AAV gene therapy platform across multiple retinal and rare disease indications.
What we're watching
- Clinical Efficacy
- Whether the 60% DRSS improvement rate can be sustained in the larger Phase IIb/III NAAVIGATE trial.
- Regulatory Pathway
- The pace at which REGENXBIO can advance sura-vec through late-stage trials and potential FDA approval.
- Market Potential
- How sura-vec's one-time treatment profile could disrupt the current anti-VEGF injection market for diabetic retinopathy.
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