REGENXBIO and AbbVie Advance Sura-Vec for Diabetic Retinopathy

REGENXBIO and AbbVie Advance Sura-Vec for Diabetic Retinopathy

By, Admin 11 August 2025

REGENXBIO Inc. announced plans to initiate a pivotal phase IIb/III clinical trial for its investigational therapy, surabgene lomparvovec (sura-vec, ABBV-RGX-314), in diabetic retinopathy (DR) via suprachoroidal delivery.
This move is paired with an amendment to its eye-care collaboration with AbbVie.

Key Drivers for the Trial Launch

  • Positive two-year phase II ALTITUDE trial data.
  • Long-term follow-up results enabling a global clinical program for DR.

Executive Comments

Steve Pakola, M.D., Chief Medical Officer, REGENXBIO:

“Advancing our DR programme to late-stage development brings sura-vec closer to becoming a transformative treatment for millions living with DR.”

Primal Kaur, M.D., SVP, Global Development, AbbVie:

“DR is progressive, leading to vision-threatening events and is the leading cause of blindness among working-age adults. We aim to address unmet needs and offer new patient options.”

Phase II ALTITUDE Trial Insights

  • Patient Group: Non-proliferative diabetic retinopathy (NPDR).
  • Dose Levels Tested: 1, 2, and 3.
  • Safety Profile:
    - Well tolerated across all dose levels.
    - No drug-related serious adverse events.
    - No intraocular inflammation through two years at dose level 3 (1.0×10¹² GC/eye) with short-course topical prophylactic steroids.
  • Sample Size: n = 15 for dose level 3.
  • Updated results to be presented at a future medical meeting.

Upcoming Phase IIb/III Trial

  • Design: Two-part, placebo-controlled.
  • Primary Endpoint: > 2-step DRSS improvement at 1 year.
  • Support Data: Phase II dose level 3 results.
  • Status: Site selection in progress.

Collaboration and Licensing Amendment

  • Original agreement signed: September 10, 2021.
  • Updated Milestone Structure:
    - $100M from AbbVie upon first subject dosed in phase IIb/III.
    - Additional $100M upon first subject dosed in a second phase III trial.
  • Funding:
    - REGENXBIO to fund phase IIb.
    - AbbVie to fund the phase III ACHIEVE trial in wet AMD.

ACHIEVE Trial in Wet AMD

  • Objective: Assess reduction in injection burden and preservation of long-term vision.
  • Design: Randomized controlled trial.
  • Comparison: Sura-vec vs standard of care.

About Sura-Vec

  • Mechanism: NAV AAV8 vector encoding an antibody fragment to inhibit vascular endothelial growth factor (VEGF).
  • Potential: One-time treatment for wet AMD, DR, and other chronic retinal conditions.
  • Action: Blocks VEGF pathway to prevent growth of leaky blood vessels and retinal fluid accumulation.

Diabetic Retinopathy – Background

  • Prevalence: Affects nearly 10 million people in the U.S.
  • Age Group: Leading cause of vision loss in adults aged 24–75.
  • Progression:
    - Ranges from NPDR to proliferative diabetic retinopathy (PDR).
    - Can lead to diabetic macular edema (DME) and blindness.
  • Current Treatments:
    - NPDR: Watchful waiting or anti-VEGF treatment.
    - PDR: Anti-VEGF, retinal laser, or surgery for advanced cases.

About REGENXBIO

Founded in 2009, REGENXBIO is a biotechnology leader in AAV gene therapy, dedicated to harnessing the curative potential of genetic medicine.

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