REGENXBIO Launches Phase 2b/3 Trial of Sura-Vec for Diabetic Retinopathy

REGENXBIO has initiated a pivotal phase 2b/3 clinical trial for surabgene lomparvovec (sura-vec, ABBC-RGX-314) in the treatment of diabetic retinopathy (DR), utilizing suprachoroidal delivery. This milestone comes on the heels of positive two-year results from the phase 2 ALTITUDE trial.

Positive Safety Profile from ALTITUDE Trial

The ALTITUDE trial evaluated sura-vec in subjects with non-proliferative diabetic retinopathy (NPDR) at three dose levels. As of June 9, 2025, sura-vec was well-tolerated across all tested doses, with no drug-related serious adverse events and no intraocular inflammation reported through two years at dose level 3.

“Advancing our DR program to late-stage development brings sura-vec closer to being a potentially transformative new treatment for the millions of people living with DR,” said Steve Pakola, MD, Chief Medical Officer at REGENXBIO. “We remain committed to advancing this program to maximize its value and impact for patients worldwide.”

Mechanism of Action and Broader Development Program

Sura-vec uses the NAV AAV8 vector to deliver an antibody fragment that inhibits vascular endothelial growth factor (VEGF). In addition to DR, the therapy is also being investigated as a potential one-time treatment for wet age-related macular degeneration (AMD) and other chronic retinal diseases.

“DR is a progressive disease, with most patients eventually developing vision-threatening events, and is the leading cause of blindness among working-age adults,” noted Primal Kaur, MD, Senior Vice President, Global Development of Immunology, Neuroscience, Eye Care and Specialty at AbbVie.

Collaboration with AbbVie and Updated Milestones

REGENXBIO and AbbVie have amended their September 2021 collaboration and license agreement for the DR program, updating the milestone payment structure:

       • AbbVie will pay REGENXBIO $100 million upon dosing the first subject in the phase 2b/3 trial.

       • AbbVie will pay an additional $100 million upon dosing the first subject in the second phase 3 trial.

       • REGENXBIO will cover the costs for the phase 2b portion of the phase 2b/3 trial.

“We are excited to advance this clinical development program with the goal of helping address these unmet needs and bring an additional option to patients living with DR,” Kaur added.