On 18 April 2025, Regeneron announced that it received a complete response letter (CRL) from the US FDA regarding the supplemental Biologics Licence Application (sBLA) for Eylea HD® (aflibercept, 8mg injection) with extended dosing intervals (up to every 24 weeks) across all approved indications.
Eylea HD® is currently approved in the US with dosing intervals of every 8-16 weeks for nAMD and diabetic macular oedema (DME), and every 8-12 weeks for diabetic retinopathy (DR), following 3 initial monthly doses. According to Regeneron, the CRL “did not identify any issues with the safety or efficacy of Eylea HD® in its approved indications and dosing regimens”. Regeneron is “evaluating the FDA’s decision and will determine a path forward in due course.”
This news comes only a day after Regeneron’s sBLA for Eylea HD® for treatment of macular oedema following retinal vein occlusion (RVO), and for broadening the dosing schedule to include monthly dosing across approved indications, was accepted by the FDA for Priority Review. The FDA’s target action date is 19 August 2025.
Eylea HD® (known as Eylea™ 8mg in Europe) was jointly developed by Bayer and Regeneron. Regeneron holds the exclusive rights to both 2mg and 8mg Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.
Bayer filed an application with the European Medicines Agency (EMA) for approval of Eylea™ 8mg for the treatment of macular oedema following RVO earlier in April 2025.