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FDA approves labeling clarifications for Eylea
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The FDA has approved updated U.S. prescribing information for Eylea, Regeneron announced.
The update was made in response to concerns expressed by the American Society of Retina Specialists about misinterpretation of label language, the society said in a press release.
Eylea (aflibercept) is indicated for neovascular age-related macular degeneration, diabetic macular edema, and diabetic retinopathy in patients with DME.
According to a press release from Regeneron, the label clarification recognizes that while most patients who receive aflibercept will require dosing every 8 weeks after an initial monthly dosing period, some patients will still require monthly dosing.
“The label clarification provides clearer direction on the approved dosing option of up to an every 4-week interval that has been described in the U.S. prescribing information since the initial approval for Eylea in 2011,” the release said.
The revised U.S. dosing and administration guidance for neovascular AMD includes the following clarifications, which are italicized:
“Although Eylea may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when Eylea was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 weeks (monthly) dosing after the first 12 weeks (3 months).”
The revised U.S. dosing and administration guidance for DME and DR includes the following clarifications, which are italicized:
“Although Eylea may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when Eylea was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 weeks (monthly) dosing after the first 20 weeks (5 months).”