Patients with DME can maintain longer treatment intervals with 8 mg aflibercept
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CHICAGO — Patients with diabetic macular edema maintained vision at longer injection intervals with 8 mg intravitreal aflibercept, according to a study presented at Retina Subspecialty Day at the American Academy of Ophthalmology meeting.
David M. Brown, MD, said DME levels are increasing in the United States, and the condition continues to have a high treatment burden.
“Our current VEGF drugs, although great and revolutionary, often require monthly or near monthly dosing to control diabetic macular edema,” he said.
In the phase 2/3 PHOTON study, researchers assessed the safety and efficacy of an 8 mg formulation of aflibercept; 658 patients were randomly assigned to undergo treatment with 2 mg aflibercept every 8 weeks, 8 mg aflibercept every 12 weeks or 8 mg aflibercept every 16 weeks after initial monthly injections. The primary endpoint was mean change in best corrected visual acuity at week 48.
At weeks 16 or 20, patients in the 12-week and 16-week groups who did not meet dose regimen modification criteria were shortened to every 8 weeks. At week 24, patients in the 16-week group who did not meet criteria were shortened to every 12 weeks. After that, patients receiving 8 mg dosing who did not meet criteria were shortened to every 4 weeks. The criteria were a greater than 10 letter loss in BCVA from week 12 and a greater than 50 µm increase in central retinal thickness from week 12.
Brown said all three groups showed a robust increase in visual acuity, and the 8 mg 12-week and 16-week dosing regimens were noninferior to the 2 mg 8-week dosing regimen (P < .0001 and P = .0031, respectively).
Additionally, 91% of patients in the 12-week group and 89% of patients in the 16-week group maintained treatment at their randomized intervals at week 48. Brown said 93% of patients who received the 8 mg dose maintained dosing intervals of at least 12 weeks.
“These 48-week results show noninferiority of 8 mg [every 12 weeks] or [every 16 weeks] despite greatly increased dosing intervals,” Brown said. “We hope to get this benefit out to our patients in the coming future.”
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Brown DM. Intravitreal aflibercept injection 8 mg for diabetic macular edema: 48-week results from the phase 2/3 PHOTON trial. Presented at: American Academy of Ophthalmology meeting; Sept. 30-Oct. 3, 2022; Chicago.
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