Table of contents
Byooviz is a medicine used to treat adults with certain sight problems caused by damage to the retina (the light-sensing layer at the back of the eye), and more specifically its central region, known as the macula. The macula provides the vision needed to see detail for everyday tasks such as driving, reading and recognising faces. Byooviz is used to treat:
- ‘wet’ form of age-related macular degeneration (AMD). The wet form of AMD is caused by choroidal neovascularisation (abnormal growth of blood vessels beneath the retina, which may leak fluid and blood and cause swelling);
- macular oedema (swelling of the macula) caused by diabetes or by occlusion (blockage) of the veins behind the retina;
- proliferative diabetic retinopathy (growth of abnormal tiny blood vessels in the eye, associated with diabetes);
- other sight problems associated with choroidal neovascularisation.
Byooviz is a ‘biosimilar medicine’. This means that Byooviz is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Byooviz is Lucentis. For more information on biosimilar medicines, see here.
Byooviz contains the active substance ranibizumab.
Byooviz : EPAR - Medicine overview (PDF/143.31 KB)
First published: 08/09/2021
Byooviz : EPAR - Risk-management-plan summary (PDF/66.24 KB)
First published: 08/09/2021
Last updated: 23/11/2022
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This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.
Samsung Bioepis NL B.V.
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Olof Palmestraat 10
21/02/2023 Byooviz - EMEA/H/C/005545 - IB/0010
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Byooviz is indicated in adults for:
- The treatment of neovascular (wet) age-related macular degeneration (AMD)
- The treatment of visual impairment due to diabetic macular oedema (DME)
- The treatment of proliferative diabetic retinopathy (PDR)
- The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)
The treatment of visual impairment due to choroidal neovascularisation (CNV)