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EMA Product

Lucentis

Product approved by European Medicines Agency (EU)

Basic Information

Lucentis

Regulatory Information

EMEA/H/C/000715

Authorised

January 22, 2007

November 16, 2006

46

May 12, 2025

Company Information

Ireland

Vista Building Elm Park Merrion Road Dublin 4

NOVARTIS EUROPHARM LIMITED

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Lucentis is indicated in adults for: - The treatment of neovascular (wet) age-related macular degeneration (AMD) - The treatment of visual impairment due to choroidal neovascularisation (CNV) - The treatment of visual impairment due to diabetic macular oedema (DME) - The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)

Overview Summary

Lucentis 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. In adults, Lucentis 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. Lucentis is also used in preterm infants to treat retinopathy of prematurity, 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. It is only used for specific stages of the disease (zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) as well as the rapidly progressing, severe form of the disease called aggressive posterior retinopathy disease). Lucentis contains the active substance ranibizumab.

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