Diana V. Do, MD: 3-Year PHOTON Data on Aflibercept 8 mg for DME

Positive 3-year data from the Phase 3 PHOTON extension trial showed patients with diabetic macular edema (DME) achieved durable vision gains, anatomic improvement, and extended dosing intervals with aflibercept 8 mg (EYLEA HD) treatment.

Most patients (88%) who continued treatment with aflibercept 8 mg in the PHOTON extension study achieved a last dosing interval of ≥12 weeks at Week 156, while those switched to aflibercept 8 mg experienced notably halted fluid reaccumulation.

These data were presented in a late-breaking session at the 128th Annual American Academy of Ophthalmology (AAO) Meeting.

In an interview with HCPLive, presenter Diana V. Do, MD, a professor of ophthalmology at the Byers Eye Institute, Stanford University, described the benefit clinicians are seeing with aflibercept 8 mg for DME treatment, for both treatment-naive patients and those with a history of anti-vascular endothelial growth factor (VEGF) agents.

“We’ve had positive feedback suggesting that clinicians are seeing benefits in both reductions in retinal thickness and improvements in visual acuity, but more importantly, they’re able to extend the treatment duration and allow for fewer injections, decreasing the burden to patients and caregivers, while maintaining these excellent visual acuity outcomes,” Do told HCPLive.

The PHOTON trial randomized patients to 12- or 16-week dosing intervals of aflibercept 8 mg, after 3 monthly doses. Per pre-specified criteria, dosing intervals could be shortened in the trial or extended in the second and third years. Initial reported data found that 89% of all patients who completed Week 96 maintained ≥12-week intervals with aflibercept 8 mg.

Participants could participate in an optional extension study for an additional 60 weeks, of which 152 patients completed the full 156 weeks of treatment. Approximately 88% were assigned a dosing interval of ≥12 weeks, with 48% assigned a dosing interval of ≥20 weeks, at the end of 3 years of PHOTON.

Ultimately, vision gains and anatomical improvements seen through Year 2 in PHOTON were sustained across Year 3 in the extension study.

Participants in the PHOTON comparator arm received aflibercept 2 mg with an 8-week dosing for 96 weeks after 5 initial monthly doses and could enter the extension study at Week 96 and switch to a 12-week dosing interval with aflibercept 8 mg. Among those who completed the extension (n = 58), 83% achieved a last assigned dosing interval ≥12 weeks at the end of the study.

These patients also experienced substantially slower fluid reaccumulation after the first dose of aflibercept 8 mg, compared with their previous rate of fluid reaccumulation on aflibercept 2 mg. The overall safety profile of aflibercept 8 mg in these data remained consistent with aflibercept 2 mg and generally consistent with the known profile of aflibercept 8 mg in its pivotal trials.

“Retina innovation is always evolving, and with the advent of aflibercept 8 mg, and other agents, such as faricimab, it’s really made a difference in our clinical practice,” Do told HCPLive. “It’s going to be exciting to see future clinical trial data from gene therapy and other mechanisms of action, which might complement some of our VEGF inhibition.”

Disclosures: Relevant disclosures for Do include Abbvie, Apellis, Genentech, Regeneron, and others.

Reference

_{Do DV. Aflibercept 8 mg in DME: Key Results from the PHOTON Extension Study. Presented at the American Academy of Ophthalmology (AAO) 2024 Meeting. Chicago, Illinois. October 18-21, 2024.}

_{Three-year results for Eylea HD® (aflibercept) injection 8 mg demonstrate continued durable vision gains and anatomic improvements with extended dosing intervals in patients with diabetic macular edema. Regeneron Pharmaceuticals Inc. October 18, 2024. Accessed October 19, 2024. https://investor.regeneron.com/news-releases/news-release-details/three-year-results-eylea-hdr-aflibercept-injection-8-mg.}