Surabgene lomparvovec (sura-vec, ABBV-RGX-314) - (NAAVIGATE)

June 29, 2026: REGENXBIO Inc. (NASDAQ: RGNX) announced the first patient was dosed in the Phase IIb/III NAAVIGATE trial of investigational surabgene lomparvovec (sura-vec, ABBV-RGX-314) for diabetic retinopathy (DR) using suprachoroidal delivery; the company will receive a $100 million milestone payment from AbbVie.

NAAVIGATE is a multicenter, randomized, masked, sham-controlled study in non-proliferative DR without center-involved diabetic macular edema. Patients receive sura-vec at 1.0×10^12 genome copies/eye (ALTITUDE dose level 3) plus short-course topical prophylactic steroids. The primary endpoint is >2-step improvement on the diabetic retinopathy severity scale (DRSS) at one year. The Phase IIb portion (run by REGENXBIO) is expected to enroll ~135 U.S. participants.

Upcoming catalysts: REGENXBIO plans to present 2.5-year long-term follow-up data from the ALTITUDE trial at the ASRS 44th Annual Meeting (July 2026); it also plans to present five-year Phase I/IIa long-term follow-up data for subretinal sura-vec in wet AMD at ASRS. Topline data (with AbbVie) from the pivotal ATMOSPHERE and ASCENT wet AMD trials (subretinal delivery) are expected in Q4 2026.