REGENXBIO to receive $100M milestone as first patient dosed in Phase IIb/III sura-vec diabetic retinopathy trial

REGENXBIO announced it earned a $100.0 million milestone tied to dosing the first patient in the Phase IIb/III NAAVIGATE trial of surabgene lomparvovec for diabetic retinopathy.

Key Highlights:

• REGENXBIO earned a $100.0M milestone payment from AbbVie for first patient dosing in the Phase IIb/III NAAVIGATE trial.
• The milestone relates to dosing in a suprachoroidal delivery study of sura-vec for diabetic retinopathy; payment expected in July 2026.
• NAAVIGATE is randomized, masked, sham-controlled; primary endpoint is >2-step DRSS improvement at one year.
• Phase IIb will enroll ~135 US participants at a dose of 1.0x10^12 GC/eye and includes short-course topical prophylactic steroids.
• REGENXBIO will present two- and five-year long-term data from ALTITUDE and Phase I/IIa wet AMD studies at ASRS 2026; topline pivotal trial data expected Q4 2026.

Original SEC Filing:

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