Basic Information
Eydenzelt
Regulatory Information
EMEA/H/C/005899
February 12, 2025
December 12, 2024
1
May 16, 2025
Company Information
Hungary
1062 Budapest Váci út 1-3. WestEnd Office Building B torony
Celltrion Healthcare Hungary Kft
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Eydenzelt 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).
Overview Summary
Eydenzelt a 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). Eydenzelt contains the active substance aflibercept and is a biological medicine. It is a ‘biosimilar medicine’; this means that Eydenzelt is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Eydenzelt is Eylea. For more information on biosimilar medicines, see [here](https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines).