On 2 April 2026, Regeneron announced that the FDA has approved an extended dosing interval for Eylea HD® (aflibercept 8mg, “high dose”) of up to every 20 weeks for patients with nAMD and diabetic macular oedema (DME), following one year of successful response based on visual and anatomic outcomes. The new dosing regimen means that nAMD/DME patients can be treated as little as 2-3 times a year.
The approval of the extended dosing regimen is based on 96 week data from the PHOTON and PULSAR trials. It follows FDA approval of Eylea® HD in November 2025 for RVO with up to 8 weekly dosing after an initial monthly dosing period, and a 4-weekly dosing option for patients who may benefit from resuming this dosing schedule across approved indications (nAMD, DME, DR and RVO).
Regeneron’s pre-filled syringe (PFS) supplementary BLA for Eylea HD® has an FDA target action date in April 2026. The BLA had been on hold while Regeneron sought to resolve inspection findings at Catalent reported in an October 2025 Complete Response Letter from the FDA. Catalent (part of Novo Nordisk) is the manufacturer filler included in Regeneron’s sBLA. Regeneron had planned to submit to the FDA an application to include an alternate PFS manufacturing filler for its Eylea HD® BLA by January 2026.
Eylea HD® (known as Eylea™ 8mg in other jurisdictions), 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.
High dose Eylea® is approved for RVO in the US (November 2025), Europe (January 2026), the UK (February 2026) and Korea (February 2026). It is also approved for nAMD and DME (as intravitreal injection) in those and multiple other countries, including Australia (June 2024). Eylea™ 8mg pre-filled syringe (OcuClick™) was approved in Europe (September 2024), Australia (October 2024) and Korea (August 2025).
Alvotech is developing AVT29, a biosimilar to Regeneron/Bayer’s Eylea™ 8mg. In June 2024, Alvotech entered into an agreement with Advanz Pharma in relation to the commercialisation of AVT29 in Europe. Teva holds commercialisation rights for AVT29 (and AVT06, aflibercept 2mg) in the US. Alvotech has recently indicated that it expects to file the first regulatory submission for AVT29 sometime in 2026.
Biosimilars of Regeneron/Bayer’s Eylea® (aflibercept, 2mg) are already on the market around the world, including, for example, Alvotech’s Mynzepli® (launched in the UK, Canada and Japan), Amgen’s Pavblu® (available in the US), Sandoz’s Afqlir®/Enzeevu® (launched in the UK, Australia and Canada), Samsung Bioepis’ Afilivu® (available in Korea) and Celltrion’s Eydenzelt® (launched in the UK and Europe).