Posted by Michael Wonder on 20 Aug 2025
Eylea HD (aflibercept) injection 8 mg applications for expanded US label and pre-filled syringe receive FDA review period extension
20 August 2025 - Regeneron Pharmaceuticals today announced that the US 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 prior approval supplement for the Eylea HD pre-filled syringe and a supplemental biologics license application seeking approval for both the treatment of macular oedema following retinal vein occlusion and the broadening of the dosing schedule to include every 4 week (monthly) dosing across approved indications.
