Eylea hd® (aflibercept) injection 8 mg applications for expanded u.s. label and prefilled syringe receive fda review period extension

Tarrytown, n.y., aug. 20, 2025 (globe newswire) -- regeneron pharmaceuticals, inc. (nasdaq: regn) today announced that the u.s. food and drug administration (fda) has extended the target action dates to the fourth quarter of 2025 for two eylea hd® (aflibercept) injection 8 mg regulatory submissions. this includes a chemistry, manufacturing and controls (cmc) prior-approval supplement (pas) for the eylea hd prefilled syringe and a supplemental biologics license application (sbla) seeking approval for both the treatment of macular edema following retinal vein occlusion (rvo) and the broadening of the dosing schedule to include every 4-week (monthly) dosing across approved indications.
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