REGENXBIO doses first patient in Phase IIb/III diabetic retinopathy trial, triggers $100M payment

REGENXBIO announced on June 29, 2026 that dosing has begun for the first participant in the Phase IIb/III trial called NAAVIGATE, testing investigational surabgene lomparvovec (sura-vec, ABBV-RGX-314) as a treatment for diabetic retinopathy delivered via the suprachoroidal route.¹ This dosing event triggers a $100 million payment to REGENXBIO from AbbVie.¹ The company's 8-K filing states the milestone falls under the Collaboration and License Agreement originally dated September 10, 2021 and amended August 5, 2025, and the payment is expected to arrive in July 2026.¹

Trial design details: NAAVIGATE is a Phase IIb/III multicenter, randomized, masked, sham-controlled study enrolling subjects with non-proliferative diabetic retinopathy without center-involved diabetic macular edema.¹ Participants will receive sura-vec at a dose of 1.0x10^12 genome copies per eye, the same level tested as dose level 3 in the earlier Phase II ALTITUDE trial, along with short-course topical steroids.¹ The primary endpoint measures at least a 2-step improvement on the diabetic retinopathy severity scale at one year.¹ REGENXBIO expects the Phase IIb portion, which it is operationalizing, to enroll roughly 135 participants across the United States.¹

On related pipeline timing, the company said it will present two-and-a-half-year follow-up data from the ALTITUDE trial at the American Society of Retina Specialists' 44th Annual Meeting in July 2026.¹ Separately, REGENXBIO said it plans to report topline results with AbbVie from the ATMOSPHERE and ASCENT pivotal trials, which use subretinal (rather than suprachoroidal) delivery of sura-vec, in the fourth quarter of 2026.¹