REGENXBIO to present five-year RGX-314 wet AMD gene therapy data in July
The ASRS presentation extends a durability record already tied to reduced anti-VEGF injections, arriving as AbbVie's subretinal pivotal trials near a Q4 2026 readout.
Executive Summary
- REGENXBIO will present long-term follow-up data from its earliest RGX-314 wet AMD trial, extending a durability record built over multiple years of prior disclosures rather than introducing a new controlled result.
- The data feed directly into how investors read AbbVie's larger pivotal trials of the same subretinal therapy, which are approaching their own topline readout later this year.
- Prior cohorts from this same trial showed reduced injection burden and stable or improved vision through three years, so the five-year cut mainly tests whether that effect holds rather than fades.
- Gene therapy is still a limited slice of a broader anti-VEGF field, with only a handful of programs advancing the same one-time subretinal approach behind this trial's results.
The presentation
REGENXBIO Inc. plans to present five-year long-term follow-up data from the Phase 1/2a subretinal study of surabgene lomparvovec (RGX-314, marketed in partnership as ABBV-RGX-314) in neovascular age-related macular degeneration at the ASRS 44th Annual Meeting in July 2026. The trial, registered as NCT03066258, enrolled 42 patients across five dose cohorts and completed its primary endpoint period with a primary completion date of November 24, 2019. The study formally moved to Completed status in ClinicalTrials.gov records on May 18, 2023, when results were first posted. REGENXBIO+1REGENXBIO Announces First Patient Dosed in Phase IIb/III NAAVIGATE Trial of Surabgene Lomparvovec in Diabetic Retinopathy; Company to Receive $100 Million MilestoneJun 29, 2026Safety and Tolerability of RGX-314 (Investigational Product) Gene Therapy for Neovascular AMD TrialNCT03066258
What the trial already showed
The primary endpoint measured ocular and non-ocular adverse events and serious adverse events through 26 weeks, a safety and tolerability readout rather than an efficacy-powered comparison. Interim data reported from this same trial at earlier timepoints found Cohort 3 patients gained a mean of 12 ETDRS letters of vision at three years, with a mean annualized anti-VEGF injection rate reduced 66.7%. High-dose subretinal cohorts 4 and 5 showed stable visual acuity and decreased central retinal thickness at 1.5 years. The five-year data due in July extend that same cohort-level durability record rather than introducing a new controlled comparison. NCT03066258+1Safety and Tolerability of RGX-314 (Investigational Product) Gene Therapy for Neovascular AMD TrialNCT03066258REGENXBIO Announces First Patient Dosed in Phase IIb/III NAAVIGATE Trial of Surabgene Lomparvovec in Diabetic Retinopathy; Company to Receive $100 Million MilestoneJun 29, 2026
Why this matters now
REGENXBIO's partner AbbVie has carried the subretinal delivery approach into two pivotal trials, ATMOSPHERE and ASCENT, with topline data expected in the fourth quarter of 2026. The five-year follow-up gives investors the most mature durability readout available for the delivery route and dosing approach those pivotal trials are testing at scale, ahead of that separate readout. AbbVie has separately dosed the first patient in the Phase 2b/3 NAAVIGATE trial testing suprachoroidal delivery of the same molecule in diabetic retinopathy, triggering a $100 million milestone payment to REGENXBIO, underscoring how actively the asset is advancing across indications and delivery routes. REGENXBIOREGENXBIO Announces First Patient Dosed in Phase IIb/III NAAVIGATE Trial of Surabgene Lomparvovec in Diabetic Retinopathy; Company to Receive $100 Million MilestoneJun 29, 2026
The competitive field
Gene therapy for VEGF-driven wet AMD remains a comparatively narrow slice of a field still dominated by intravitreal anti-VEGF antibodies. Direct comparators using the same one-time subretinal or ocular gene-therapy approach include AbbVie's own follow-on RGX-314 pivotal trial, Sanofi's SAR402663, and early-stage programs from Guangzhou Jiayin Biotech and Exegenesis Bio, most still in Phase 1 or Phase 1/2. Across VEGF-targeted trials in this indication, prior Phase 1 attempts show a 14% failure rate on a base of 6 completed and 1 terminated trial. That leaves durability data like the five-year cut as one of the few maturity benchmarks available for this delivery approach.
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