Eylea is a medicine used to treat adults with:
- the ‘wet’ form of age-related macular degeneration (AMD), a disease which affects the central part of the retina (called the macula) at the back of the eye. The wet form of AMD is caused by choroidal neovascularisation (the abnormal growth of blood vessels under the macula), which may leak fluid and blood and cause swelling;
- impaired vision due to macular oedema (swelling) that follows blockage of either the main vein carrying blood from the retina (known as central retinal vein occlusion, CRVO) or of smaller branch veins (known as branch retinal vein occlusion, BRVO);
- impaired vision due to macular oedema caused by diabetes;
- impaired vision due to myopic choroidal neovascularisation (a severe type of short-sightedness where the eyeball continues to grow, becoming longer than it should be).
Eylea is also used to treat preterm infants with retinopathy of prematurity (ROP), an eye condition that can occur when a baby is born too early and blood vessels in the eye do not develop normally, causing damage to the retina. Eylea is used for specific stages of the disease: zone I (stage 1+, 2+, 3 or 3+) and zone II (stage 2+ or 3+) as well as the rapidly progressing severe form of the disease called aggressive posterior retinopathy disease.
Eylea contains the active substance aflibercept.
Eylea : EPAR - Medicine overview (PDF/182.76 KB) (updated)
First published: 05/12/2012
Last updated: 10/01/2023
Eylea : EPAR - Risk-management-plan summary (PDF/302.5 KB) (updated)
First published: 10/08/2018
Last updated: 10/01/2023
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|Date of issue of marketing authorisation valid throughout the European Union||
09/12/2022 Eylea - EMEA/H/C/002392 - II/0077/G
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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Eylea is indicated for adults for the treatment of:
- neovascular (wet) age-related macular degeneration (AMD);
- visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO);
- visual impairment due to diabetic macular oedema (DME);
- visual impairment due to myopic choroidal neovascularisation (myopic CNV).
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 202211/11/2022
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 September 201525/09/2015
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 January 201523/01/2015