Early ELAAVATE Data Show Promise in DME

Clinical Report: Early ELAAVATE Data Show Promise in DME

Overview

At the 2026 American Academy of Ophthalmology meeting, Arshad M. Khanani, MD, FASRS, reported preliminary findings from ELAAVATE, an investigator-initiated phase 2 study of subretinal sura-vec (ABBV-RGX-314) for center-involving diabetic macular edema (DME). In nine surgeries to date, he reported no new safety signals or surgical complications, and described a dose-dependent response with most participants receiving zero or one supplemental injection. Enrollment and follow-up are ongoing, and the findings are preliminary.

Background

Center-involving DME can threaten vision and often requires ongoing treatment. Current guidance identifies intravitreal anti-VEGF therapy as an initial treatment for center-involving DME with vision loss, with laser or intravitreal corticosteroids among options in selected circumstances. ELAAVATE is investigating whether subretinal gene therapy can provide disease control with fewer supplemental injections in previously treated patients. The study is also assessing feasibility and safety in phakic and pseudophakic patients.

Data Highlights

Measure	Reported finding
Study	Investigator-initiated phase 2 ELAAVATE study of subretinal sura-vec (ABBV-RGX-314) in center-involving DME
Surgeries performed to date	9
Safety and surgical complications	No new safety signals or complications reported by the presenter
Supplemental injections	Most patients had received 0 or 1; the presenter described a dose-dependent response, with disease control maintained without injections in many patients, particularly at the high dose
Immunosuppression described	Topical steroid taper over one month; no oral or long-term topical immunosuppression reported as necessary

Key Findings

ELAAVATE is evaluating subretinal sura-vec in patients with center-involving DME; participants were previously treated with anti-VEGF agents, and many had received second-generation agents.
Khanani reported nine surgeries, including in phakic and pseudophakic patients, with no new safety signals or surgical complications observed to date.
Retinal pigmentary changes were observed; the presenter said they occurred later and were less intense than those seen in neovascular AMD patients.
The presenter described a dose-dependent response and reported that most patients had received zero or one supplemental injection, with disease control maintained without injections in many patients, especially at the high dose.
The reported postoperative regimen included a topical steroid taper over a month; Khanani said oral or long-term topical immunosuppression was not required based on the experience described.
Related SPECTRA coverage describes a separate phase 2a study of 4D-150 gene therapy in adults with DME; it is distinct from ELAAVATE and does not establish ELAAVATE outcomes.

Clinical Implications

The ELAAVATE report provides early safety and disease-control observations for subretinal sura-vec in previously treated DME, but the cohort remains small and enrollment is ongoing. The source does not establish comparative efficacy or support replacing established DME treatments; the presenter said larger trials would be needed to confirm the findings.

Conclusion

Early ELAAVATE findings reported by the investigator include no new safety signals in nine surgeries and a preliminary signal of disease control with few supplemental injections. Further enrollment and larger studies are needed to confirm safety and efficacy.