REGENXBIO launches phase 2b/3 trial of sura-vec for diabetic retinopathy

(Image Credit: AdobeStock/SergeVo)

REGENXBIO recently announced the initiation of a pivotal phase 2b/3 clinical trial for surabgene lomparvovec (sura-vec, ABBC-RGX-314) for the treatment of diabetic retinopathy (DR) using suprachoroidal delivery.¹

This phase 2b/3 trial follows new, positive 2-year data from the phase 2 ALTITUDE trial, in which sura-vec was well-tolerated in subjects with non-proliferative diabetic retinopathy (NPDR) at dose levels 1, 2, and 3.¹ According to a press release, as of June 9, 2025, no drug-related serious adverse events were documented for sura-vec, and no intraocular inflammation was observed through 2 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,” Steve Pakola, MD, Chief Medical Officer, REGENXBIO, said in a press release.

“We remain committed to advancing this program to maximize its value and impact for patients worldwide.”

In addition to the treatment of DR, sura-vec is being investigated as a potential one-time treatment for wet age-related macular degeneration (AMD) and other chronic retinal conditions. The drug consists of the NAV AAV8 vector, which encodes an antibody fragment designed to inhibit VEGF.¹

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

REGENXBIO and AbbVie, which reached a collaboration and license agreement between the two companies in September 2021, have executed an amendment to the agreement, which includes an updated milestone structure for the DR program.

In this new agreement, AbbVie will pay GEGENXBIO $100 million upon the first subject dosed in the phase 2b/3 trial and an additional $100 million upon the first subject dosed in the second phase 3 clinical trial. REGENXBIO will be paying for the costs for phase 2b 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 said.¹

Reference:

1. REGENXBIO Inc. REGENXBIO Announces Pivotal Program for Surabgene Lomparvovec in Diabetic Retinopathy. Prnewswire.com. Published August 7, 2025. Accessed August 8, 2025. https://www.prnewswire.com/news-releases/regenxbio-announces-pivotal-program-for-surabgene-lomparvovec-in-diabetic-retinopathy-302523972.html

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