Ozurdex is an implant that is injected into the eye.
It is used to treat adults with impaired vision due to macular oedema associated with:
- blockage of the veins carrying blood from the back of the eye;
- damage to blood vessels caused by diabetes in patients who have an artificial lens in their eye or in whom other treatment did not work or was unsuitable.
Macular oedema is swelling in the macula, the central part of the retina (the light-sensing layer at the back of the eye), which can reduce the central part of a person’s vision and affect tasks such as reading and driving.
Ozurdex is also used to treat adults with non-infectious uveitis at the back of the eye. Uveitis is inflammation of the uvea, the middle layer of the eye.
Ozurdex : EPAR - Medicine overview (PDF/92.07 KB) (updated)
First published: 05/08/2010
Last updated: 26/11/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Allergan Pharmaceuticals Ireland
|Date of issue of marketing authorisation valid throughout the European Union||
05/09/2019 Ozurdex - EMEA/H/C/001140 - II/0035
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Ozurdex is indicated for the treatment of adult patients with macular oedema following either branch retinal-vein occlusion (BRVO) or central retinal-vein occlusion (CRVO).
Ozurdex is indicated for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as noninfectious uveitis.
Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.