AbbVie's ASCENT gene-therapy trial vs. aflibercept in wet AMD nears Q4 2026 data
Sura-vec must show non-inferiority to aflibercept on vision and cut injection burden to advance as a one-time rival to standard-of-care anti-VEGF shots.
Executive Summary
- AbbVie's Phase 3 ASCENT trial is heading toward a topline readout that will test whether a one-time subretinal gene therapy can match the vision outcomes of a standard chronic anti-VEGF injection in wet age-related macular degeneration.
- A non-inferiority result would support the therapy's case as a durable alternative to lifelong intraocular injections, the treatment burden that has limited adherence under the current standard of care.
- The trial's completion date has held steady for roughly a year after three earlier delays, and enrollment closed above its original target, both of which support the case that the readout stays on its guided track.
- The therapy sits in a populated field of gene-therapy and biologic programs chasing the same VEGF-A target in wet AMD, including a direct AbbVie-sponsored companion trial and rival subretinal and intravitreal gene therapies, so this readout will be read against that broader class rather than in isolation.
The catalyst
REGENXBIO and AbbVie completed enrollment in the ASCENT and companion ATMOSPHERE pivotal trials of surabgene lomparvovec (sura-vec, ABBV-RGX-314) in October 2025, putting more than 1,200 participants across both studies and setting up topline data in the fourth quarter of 2026. ASCENT, registered as NCT05407636, is a randomized, quadruple-masked, active-controlled Phase 3 trial run in the United States and the United Kingdom comparing subretinal sura-vec against aflibercept in adults with wet AMD who have already responded to anti-VEGF therapy. "We are highly encouraged by the safety and long-term durability seen in multiple earlier-stage trials," REGENXBIO Chief Medical Officer Steve Pakola said, adding that the companies "look forward to sharing the topline data next year and advancing global registration". REGENXBIO+1REGENXBIO Announces Completion of Enrollment in Pivotal Trials of Subretinal Surabgene Lomparvovec for Wet AMDOct 6, 2025Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMDNCT05407636
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the trial tests
The trial's registered primary endpoint in its bilateral treatment substudy is the incidence of ocular adverse events and serious adverse events, while the pivotal comparison itself is designed around non-inferiority in Best Corrected Visual Acuity change from baseline against aflibercept, evaluated at one year. Secondary measures include the annualized rate of supplemental anti-VEGF injections and change in central retinal thickness, the two endpoints that would carry the therapy's core commercial argument: fewer repeat injections while holding vision steady. Because the design is built around non-inferiority rather than superiority, a positive readout would show sura-vec holds its ground on vision, not that it beats aflibercept outright. NCT05407636Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMDNCT05407636
Timing and enrollment
The trial's primary completion date moved three times between 2023 and 2025, sliding from an original April 2024 target out to October 2026, before holding unchanged for nearly a year through the most recent registry update. Enrollment grew from an original plan to 714 participants, an 8% increase over the prior 660-participant count logged in October 2024, which an operational enrollment-change model flags as within the routine range for a trial of this design. Neither shift changes the guided timing window; both read as normal trial-management housekeeping rather than a signal the readout is at risk. NCT05407636Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMDNCT05407636
Competitive frame
Sura-vec is not the only gene therapy chasing wet AMD: AbbVie itself runs a second Phase 3 trial of the same drug, NCT07007065, and 4D Molecular Therapeutics has its own Phase 3 subretinal gene therapy, 4D-150, in the same indication and target class. Adverum Biotechnologies is running two earlier-phase gene-therapy trials in the same class, and EyeBiotech and Genentech are testing non-gene-therapy VEGF-A biologics in wet AMD and diabetic macular edema. Against a standard of care built on frequent intravitreal injections that most trials in this class still use as the active comparator, the bar this readout has to clear is a vision result that holds up against aflibercept while showing the injection-frequency reduction needed to justify a one-time gene-therapy approach over the incumbent regimen.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.