Eylea

aflibercept

Table of contents

Opinion

On 10 November 2022, 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 the treatment of preterm infants with retinopathy of prematurity (ROP).

For information, the full indications for Eylea will therefore be as follows:1

Eylea is indicated for adults for the treatment of

  • neovascular (wet) age-related macular degeneration (AMD) (see section 5.1),
  • visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1),
  • visual impairment due to diabetic macular oedema (DME) (see section 5.1),
  • visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).

Eylea is indicated in preterm infants for the treatment of

  • retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 2+ or 3+) or AP-ROP (aggressive posterior ROP) disease.

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


1 New text in bold

Key facts

Name
Eylea
Agency product number
EMEA/H/C/002392
International non-proprietary name (INN) or common name
  • aflibercept
Active substance
  • aflibercept
Therapeutic area
Wet Macular Degeneration
Macular Edema
Diabetes Complications
Date opinion adopted
10/11/2022
Company name
Bayer AG
Status
Positive
Application type
Post-authorisation

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