Regenxbio said the first patient has been dosed in its Phase IIb/III Naavigate trial of surabgene lomparvovec, or Sura-vec, in diabetic retinopathy, triggering a $100 million milestone payment from AbbVie.
The company said the study is testing Sura-vec in non-proliferative diabetic retinopathy without center-involved diabetic macular edema, using a 1.0x10^12 genome copies per eye dose and short-course topical prophylactic steroids. The Phase IIb portion is expected to enroll about 135 participants in the U.S.
The dosing announcement comes after Regenxbio reported two-year data from the Altitude trial showing durable efficacy at dose level 3, with no intraocular inflammation observed in 15 patients. Regenxbio said it plans to present 2.5-year long-term follow-up data from Altitude at the American Society of Retina Specialists meeting in July 2026.
The company also said five-year follow-up data from a Phase I/IIa wet AMD study of Sura-vec will be presented at the same meeting, and that topline data from AbbVie’s Atmosphere and Ascent pivotal trials are expected in the fourth quarter of 2026. The market has reacted to these announcements by moving the company's shares 6.3% to a price of $11.14. If you want to know more, read the company's complete 8-K report here.
