Regeneron’s Eylea HD (aflibercept) Receives the US FDA’s Approval for Serious Retinal Disease

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Regeneron’s Eylea HD (aflibercept) Receives the US FDA’s Approval for Serious Retinal Disease


  • The US FDA has approved Eylea HD (8mg) for patients with wAMD, DME & DR. The recommended dose for Eylea HD is 8mg, q4w for the first 3 months across all indications, followed by 8mg, q8w-q16w in wAMD and DME & q8w-q12w for DR
  • The approval was based on the 48wk. results from the (PULSAR) in wAMD & (PHOTON) trials in DME evaluating Eylea HD vs Eylea (2mg). Eylea HD is being jointly developed by Regeneron & Bayer AG
  • Both trials met their 1EPs & showed non-inferior and clinical equivalent vision gains at 48wks. with 12 & 16wk. dosing regimens after 3 initial monthly doses vs 8wk. dosing regimen after initial monthly doses, the majority of patients were randomized at baseline to Eylea HD 12 or 16wk. dosing regimens were able to maintain dosing intervals through 48wks.

Ref: Globenewswire | Image: Regeneron

Related News:- Alvotech Entered into an Exclusive Agreement with Polifarma to Commercialize AVT06, a Proposed Biosimilar to Eylea (aflibercept) in Turkey

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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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