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Article | 2026 AAO Meeting

Early ELAAVATE Data Show Promise in DME

Arshad M. Khanani, MD, FASRS, discusses preliminary safety and efficacy findings from a phase 2 study of subretinal sura-vec gene therapy.

By: Arshad M. Khanani, MD, MA, FASRS, Diana V. Do, MD
Retinal Physician October 10, 2026

Clinical Scorecard: Preliminary ELAAVATE Findings in Center-Involving DME

At a Glance

CategoryDetail
ConditionCenter-involving diabetic macular edema (DME)
Key MechanismsSubretinal delivery of sura-vec (ABBV-RGX-314), studied for safety and efficacy and potential reduction in treatment burden.
Target PopulationPreviously anti-VEGF-treated patients with center-involving DME; both phakic and pseudophakic patients were enrolled.
Care SettingInvestigator-initiated phase 2 study involving subretinal gene-therapy surgery and follow-up.

Key Highlights

  • The investigator reported having performed 9 subretinal sura-vec surgeries; enrollment and data collection were ongoing.
  • The investigator reported no new safety signals or surgical complications in the 9 surgeries performed to date.
  • Retinal pigmentary changes were observed; the investigator said they occurred later and were less intense than in neovascular AMD patients.
  • The investigator reported a dose-dependent response and maintenance of disease control without injections in some patients; most had received 0 or 1 supplemental injection.
  • The investigator reported no immune responses and described a one-month topical steroid taper, without oral or long-term topical steroids.

Guideline-Based Recommendations

Diagnosis

    Management

    • No guideline recommendation or routine-use treatment protocol is provided. In the phase 2 study, sura-vec was administered subretinally.
    • The investigator described using a topical steroid taper of 4-3-2-1 over one month after surgery.

    Monitoring & Follow-up

    • The study is evaluating safety, visual acuity, disease control, and supplemental injection use; the investigator said data were still evolving and enrollment was ongoing.

    Risks

    • Retinal pigmentary changes were observed. The investigator reported no new safety signals or surgical complications in the 9 surgeries performed to date.
    • The investigator reported no immune responses in this early cohort.

    Patient & Prescribing Data

    Previously anti-VEGF-treated patients with center-involving DME, including phakic and pseudophakic patients.

    In this preliminary cohort, most patients received 0 or 1 supplemental injection. The investigator reported a dose-dependent response and maintenance of disease control; the article provides no dosing details and does not establish efficacy.

    Clinical Best Practices

    • The investigator said enrollment was ongoing and that a larger trial would be needed to confirm the findings.
    • The investigator described a one-month topical steroid taper and reported no need for oral or long-term topical steroids in the cohort to date.

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