Eylea - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

aflibercept

Opinion

On 11 December 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Eylea. The marketing authorisation holder for this medicinal product is Bayer AG.

The CHMP adopted a new indication for Eylea 114.3 mg/ml solution for injection, as follows:

Eylea is indicated in adults for the treatment of

• neovascular (wet) age related macular degeneration (nAMD) (see section 5.1)
• visual impairment due to diabetic macular oedema (DME) (see section 5.1)
• visual impairment due to macular oedema secondary to retinal vein occlusion (branch, central and hemiretinal RVO) (see section 5.1).

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold

CHMP post-authorisation summary of positive opinion for Eylea (EMA/VR/0000264981)

Adopted Reference Number: EMADOC-1700519818-2706651

Key facts

• Name of medicine:
  Eylea
• EMA product number:
  EMEA/H/C/002392
• Active substance:
  aflibercept
• International non-proprietary name (INN) or common name:
  aflibercept
• Therapeutic area (MeSH):
  • Wet Macular Degeneration
  • Macular Edema
  • Diabetes Complications
  • Retinal Vein Occlusion
  • Choroidal Neovascularization
• Anatomical therapeutical chemical (ATC) code:
  S01LA05
• Marketing authorisation holder:
  Bayer AG
• Date of opinion:
  11/12/2025
• Status:
  Positive