REGENXBIO Doses First Patient in Phase IIb/III Diabetic Retinopathy Trial, Triggers $100M AbbVie Milestone
Event summary
- REGENXBIO dosed the first patient in its Phase IIb/III NAAVIGATE trial for diabetic retinopathy using surabgene lomparvovec.
- The trial is a multicenter, randomized, sham-controlled study targeting non-proliferative diabetic retinopathy (NPDR).
- REGENXBIO will receive $100 million from AbbVie upon this milestone.
- Two-and-a-half-year data from the ALTITUDE trial will be presented at ASRS 2026.
- Topline data from ATMOSPHERE and ASCENT trials for wet AMD expected in Q4 2026.
The big picture
REGENXBIO's progress in the NAAVIGATE trial underscores the growing momentum behind gene therapies for chronic retinal conditions. The $100 million milestone from AbbVie highlights the strategic importance of sura-vec, which aims to replace repetitive anti-VEGF injections with a single administration. Success in this trial could position REGENXBIO as a leader in retinal gene therapy, addressing a significant unmet need in diabetic retinopathy and wet AMD.
What we're watching
- Clinical Efficacy
- Whether sura-vec can demonstrate durable efficacy and safety in the NAAVIGATE trial, supporting its potential as a one-time gene therapy for diabetic retinopathy.
- Regulatory Pathway
- The pace at which REGENXBIO and AbbVie advance sura-vec through pivotal trials and potential regulatory approvals for both diabetic retinopathy and wet AMD.
- Market Adoption
- How the shift from repeated anti-VEGF treatments to a one-time gene therapy could transform the management of chronic retinal diseases.
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