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REGENXBIO Announces First Patient Dosed in Phase IIb/III NAAVIGATE Trial of Surabgene Lomparvovec in Diabetic Retinopathy; Company to Receive $100 Million Milestone

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  • REGENXBIO Inc. announced that the first patient has been dosed in the Phase IIb/III NAAVIGATE clinical trial for surabgene lomparvovec (sura-vec) to treat diabetic retinopathy via suprachoroidal delivery.
  • REGENXBIO will receive $100 million from AbbVie following this dosing milestone.
  • The NAAVIGATE study is a multicenter, randomized, masked, sham-controlled trial evaluating sura-vec in subjects with non-proliferative diabetic retinopathy without center-involved diabetic macular edema.
  • Participants in the Phase IIb portion will receive sura-vec at 1.0x10^12 genome copies per eye & short-course topical prophylactic steroids.
  • The primary endpoint for the NAAVIGATE trial is a greater than 2-step improvement on the diabetic retinopathy severity scale at one year.
  • REGENXBIO plans to enroll approximately 135 participants in the United States for the Phase IIb portion of the study.
  • Two-and-a-half-year long-term follow-up data from the ALTITUDE trial will be presented at the ASRS 44th Annual Meeting in July 2026.
  • Two-year dose level 3 data from the ALTITUDE trial showed durable efficacy & no intraocular inflammation for the 15 subjects treated.
  • Five-year long-term follow-up data from a Phase I/IIa study of subretinal sura-vec for wet AMD will also be presented at ASRS 2026.
  • REGENXBIO expects to announce topline data from the ATMOSPHERE & ASCENT pivotal trials for subretinal sura-vec in Q4 2026.
  • Sura-vec is a one-time investigational gene therapy using the NAV AAV8 vector to encode an antibody fragment that inhibits the VEGF pathway.
  • Diabetic retinopathy is identified as the leading cause of vision loss in adults aged 24 to 75 worldwide & affects nearly 10 million people in the United States.