Diana V. Do, MD: 96-Week Results of the PHOTON Study

Updated 2-year results from the phase 3 PHOTON study suggest the visual benefits of aflibercept 8mg were sustained over 96 weeks in eyes with diabetic macular edema (DME), with these eyes able to continue their randomized dosing intervals.

The results, presented at the 127th Annual American Academy of Ophthalmology (AAO) Meeting in San Francisco, California, showed treatment with aflibercept 8 mg was associated with similar visual acuity outcomes as aflibercept 2mg, but with 6 fewer injections.

“What we’ve learned over the past decade is that treatment burden and frequent anti-VEGF injections are hard to maintain in real-world clinical practice because patients and their caregivers have other things to do than come back monthly for evaluation,” said presenting investigator Diana V. Do, MD, professor of ophthalmology and vice chair of clinical affairs at the Byers Eye Institute, Stanford University, in an interview with HCPLive. “That’s why it’s essential to develop these new medicines that can offer efficacious and safe treatments while extending the dosing interval.”

The global, randomized PHOTON clinical trial evaluated aflibercept 8mg, compared to aflibercept 2mg, in eyes with DME. The key element of the trial was looking at high-dose aflibercept doses every 12 weeks (Q12W) or every 16 weeks (Q16W), after 3 initial monthly loading doses. The primary endpoint was measured at week 48, looking at the mean change in best-corrected visual acuity (BCVA), and having a noninferiority margin, compared to aflibercept 2mg.

At week 48, results from PHOTON showed aflibercept 8 mg, dosed Q12W or Q16W, met the primary endpoint, with similar visual outcomes to aflibercept 2 mg. At the 96-week mark, investigators found these visual benefits were sustained. Eyes continued to be on randomized dosing intervals, with aflibercept 8 mg having similar visual acuity outcomes as aflibercept 2 mg, but with 6 fewer injections.

Do noted the results from PHOTON show that aflibercept 8 mg can answer the unmet need in dosing intervals, with Q12W, Q16W, and even longer intervals observed in the 2-year data. She indicated in the 2-year data, that 41% of eyes completed every 20-week (Q20W) dosing, which is dosing every 5 months, a large improvement over the standard.

In addition, the two-year data showed more than 30% of patients in the aflibercept 8 mg group could be extended to every 24-week dosing or every 6-month administration of high-dose aflibercept. Do called this extension a “game-changer.”

Do also touched on the safety of aflibercept 8mg, with the data showing comparable signals to aflibercept 2 mg. There were very low (1%) rates of intraocular inflammation, and no cases of ischemic optic neuropathy, retinal vasculitis, or artery occlusion were identified.She noted these findings are some of the most exciting developments in ophthalmology this year.

“This new generation of anti-VEGF agents, such as aflibercept 8 mg or faricimab, also offer our patients better changes of disease control with fewer injections,” Do said.

References

_{Do Diana. Aflibercept 8mg for Diabetic Macular Edema: 96-Week Results of the PHOTON Study. Presented at the 2023 American Academy of Ophthalmology Annual Meeting, November 3 – 6, 2023.}