REGENXBIO doses first patient in NAAVIGATE, phase 2b/3 sura-vec trial for diabetic retinopathy

REGENXBIO has dosed the first patient in the phase 2b/3 NAAVIGATE clinical trial of surabgene lomparvovec (sura-vec, ABBV-RGX-314) in diabetic retinopathy (DR) using suprachoroidal delivery.

Sura-vec is a 1-time investigational gene therapy designed to deliver sustained treatment in wet AMD, diabetic retinopathy and other chronic retinal conditions. It uses the NAVAAV8 vector to encode an antibody fragment designed to inhibit vascular endothelial growth factor (VEGF), which the company states is believed to inhibit the VEGF pathway, allowing leaky blood vessels to grow, which contributes to the accumulation of fluid in the retina.¹

The company is developing sura-vec in collaboration with AbbVie, a deal that was established in 2021.² Under the collaboration, REGENXBIO was responsible for the completion of the then-ongoing trials of RGX-314, while both companies will share the costs of any additional trials. AbbVie leads the clinical development and commercialization of RGX-314 globally. For the recent dosing in the NAAVIGATE trial, REGENXBIO will receive $100 million from AbbVie and an additional $100 million upon the first patient being dosed in a second phase 3 clinical trial.^2,3

Steve Pakola, MD, chief medical officer at REGENXBIO commented in a press release on the trial and partnership with AbbVie, stating, "Dosing the first patient in the Phase IIb/III study is a significant milestone in our commitment with AbbVie to bring a one-time gene therapy to patients who continue to face progressive and vision-threatening complications across multiple chronic retinal diseases. We are excited to advance sura-vec for DR, following the 2-year data that reinforced the durable and disease-modifying impact that sura-vec has the potential to deliver with a single administration. The opportunity to prevent disease progression before vision damage occurs is critical for this population, and we are collaborating closely with the investigators and AbbVie to progress this innovative treatment option."¹

The NAAVIGATE trial is a multicenter, randomized, masked, sham-controlled study to evaluate the safety and efficacy of sura-vec in patients with nonproliferative DR (NPDR) without center-involved diabetic macular edema (CI-DME).¹ The Phase IIb portion, which is being conducted by REGENXBIO, is expected to enroll approximately 135 participants in the United States. Patients will receive sura-vec at 1.0x10¹² genome copies (GC)/eye, which was evaluated as dose level 3 in the phase II ALTITUDE trial of sura-vec, and short-course topical prophylactic steroids. The primary endpoint is > 2-step improvement on the diabetic retinopathy severity scale (DRSS) at 1 year.^1-3

The company also stated it intends to release 2 ½ year data from the long term follow up study of the ALTITUDE trial at the ASRS 44^th Annual Meeting in July 2026. ALTITUDE is a multi-center, open-label, randomized, controlled, dose-escalation trial evaluating the efficacy, safety and tolerability of suprachoroidal delivery of ABBV-RGX-314 using the SCS Microinjector in patients with moderately severe or severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR).^4,5

In the phase 2 ALTITUDE trial, sura-vec was well tolerated in patients with non-proliferative diabetic retinopathy (NPDR) at dose levels 1 of 2.5x10¹¹ genomic copies per eye (GC/eye), dose level 2 at 5x10¹¹ GC/eye, and 3. In 2-year dose level 3 data from the ALTITUDE trial, sura-vec demonstrated a durable efficacy profile and was well tolerated with no intraocular inflammation observed (n=15).^4,5

References:

1. REGENXBIO Announces First Patient Dosed in Phase iib/III NAAVIGATE Trial of Surabgene Lomparvovec in Diabetic Retinopathy; Company to Receive $100 Million Milestone. Published June 29, 2026. Accessed June 30, 2026. https://www.prnewswire.com/news-releases/regenxbio-announces-first-patient-dosed-in-phase-iibiii-naavigate-trial-of-surabgene-lomparvovec-in-diabetic-retinopathy-company-to-receive-100-million-milestone-302812721.html

2. REGENXBIO Announces Closing of Eye Care Collaboration Agreement with AbbVie. Published November 9, 2021. Accessed June 30, 2026. https://ir.regenxbio.com/news-releases/news-release-details/regenxbio-announces-closing-eye-care-collaboration-agreement

3. REGENXBIO Announces Pivotal Program for Surabgene Lomparvovec in Diabetic Retinopathy. Published August 7, 2025. Accessed June 30, 2026. https://ir.regenxbio.com/news-releases/news-release-details/reg

4. REGENXBIO Presents Positive One Year Data from Phase II ALTITUDE® Trial of ABBV-RGX-314 for Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery. Published November 3, 2023. Accessed June 30, 2026. https://www.prnewswire.com/news-releases/regenxbio-presents-positive-one-year-data-from-phase-ii-altitude-trial-of-abbv-rgx-314-for-treatment-of-diabetic-retinopathy-using-suprachoroidal-delivery-301977598.html

5. Filkins K. REGENXBIO launches phase 2b/3 trial of sura-vec for diabetic retinopathy. Published August 13, 2025. Accessed June 30, 2026. https://www.ophthalmologytimes.com/view/regenxbio-launches-phase-2b-3-trial-of-sura-vec-for-diabetic-retinopathy