REGENXBIO reports 60% three-year DRSS improvement after one-time sura-vec therapy

  • REGENXBIO reported three-year ALTITUDE data for one-time sura-vec treatment in NPDR.
  • 60% of Dose Level 3 participants with three-year visits achieved more than two-step DRSS improvement.
  • Dose Level 3 is being evaluated in the Phase IIb/III NAAVIGATE trial.

REGENXBIO reported three-year interim data from the Phase II ALTITUDE® study of investigational surabgene lomparvovec, or sura-vec (ABBV-RGX-314), for diabetic retinopathy. Among Dose Level 3 participants with non-proliferative diabetic retinopathy (NPDR), 60% (6 of 10) achieved more than a two-step improvement on the Diabetic Retinopathy Severity Scale without additional diabetic-retinopathy treatment, and none experienced vision-threatening events. No new sura-vec-related safety signals or intraocular inflammation were observed through three years among 17 participants receiving short-course prophylactic topical steroids. Sura-vec is designed as a one-time gene therapy using suprachoroidal delivery (administration into a layer surrounding the eye) to provide sustained inhibition of vascular endothelial growth factor, a pathway involved in abnormal blood-vessel growth and retinal fluid accumulation. Dose Level 3 is being evaluated in the Phase IIb/III NAAVIGATE trial. The results are interim analyses from an ongoing trial and do not establish regulatory approval or future clinical success.

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