REGENXBIO doses first patient in DR trial
- REGENXBIO (NASDAQ:RGNX) dosed the first patient in its Phase IIb/III NAAVIGATE trial for diabetic retinopathy.
- The milestone triggered a $100 million payment from AbbVie under their collaboration agreement.
- The study will enroll about 135 U.S. patients and measure vision improvement over one year.
REGENXBIO (NASDAQ:RGNX) said it has dosed the first patient in the Phase IIb/III NAAVIGATE trial evaluating surabgene lomparvovec in diabetic retinopathy using suprachoroidal delivery.
The dosing milestone triggered a $100 million payment from AbbVie (NYSE:ABBV) under the companies’ existing collaboration agreement.
The NAAVIGATE study will evaluate a 1.0 × 10¹² GC/eye dose in non-proliferative diabetic retinopathy and measure outcomes using a greater-than-2-step improvement in DRSS score at one year.
The Phase IIb portion of the trial is expected to enroll about 135 participants in the United States.
REGENXBIO also said it plans to present long-term ALTITUDE and wet age-related macular degeneration data at ASRS 2026.
The company expects pivotal ATMOSPHERE and ASCENT trial topline data in the fourth quarter of 2026 as it advances its gene therapy pipeline in retinal diseases.
