Expanded Label Approved for Eylea
August 17, 2018 – The U.S. FDA has approved a label expansion for Eylea® (aflibercept) injection, manufactured by Regeneron, under the product’s indication for treatment of neovascular (wet) age-related macular degeneration (AMD).
Previously, Eylea was approved for use in AMD patients once every four or eight weeks, depending on how long they had been undergoing treatment. The newly expanded label allows for doses to be given 12 weeks apart once a patient has received effective treatment with Eylea for a full year.
The FDA originally rejected the new 12-week dosing schedule, but reversed its decision just four days later. Eylea’s updated label cautions, however, that the 12-week schedule may not be as effective as giving Eylea once every eight weeks. Prescribers should monitor their patients regularly to assess their condition.
Eylea first received FDA approval in 2011. In addition to its AMD indication, it is approved to treat macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR) in patients who have DME.