Objective:

Assess the safety and efficacy of subretinal sura-vec gene therapy in patients with center-involving diabetic macular edema (DME), including whether it can reduce treatment burden while maintaining disease control.

Approach:

• Study: Investigator-initiated phase 2 ELAAVATE study of subretinal sura-vec (ABBV-RGX-314).
• Early cohort: At the time of the interview, 9 surgeries had been performed in phakic and pseudophakic patients. Participants had previously received anti-VEGF treatment.

Key Findings:

• The investigator reported no new safety signals or surgical complications among the 9 procedures.
• Retinal pigmentary changes were observed; the investigator said they appeared later and were less intense than in neovascular AMD patients.
• The investigator reported dose-dependent response and that most patients had received 0 or 1 supplemental injection.
• According to the investigator, patients maintained disease control without injections, particularly at the high dose.
• The reported steroid regimen was a topical taper over one month; the investigator said oral or long-term topical immunosuppression was not needed.

Interpretation:

The investigator described the early data as showing a signal of efficacy and disease control, with safety comparable to the wet AMD program. Enrollment and data collection were ongoing.

Limitations:

• Findings are preliminary and based on 9 surgeries.
• The study was still enrolling, and the interview did not provide detailed outcome data or follow-up duration.

Conclusion:

The investigator said larger trials would be needed to confirm the findings.

Sources:

• Retinal Physician interview transcript provided in the article context