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New eye indication for Allergan’s Ozurdex

EU approval extends the drug's use to diabetic macular oedema

allergan ozurdex dexamethasoneAllergan's eye drug Ozurdex has been approved in the EU to treat a sight-threatening condition that affects people with diabetes.

The European Commission granted marketing authorisation to Ozurdex, an eye implant that contains the corticosteroid dexamethasone, as a treatment for adults with visual impairment due to diabetic macular oedema (DMO).

The approval covers patients have an artificial lens implant or are unsuitable for therapy with a non-corticosteroid.

DMO is common in people with diabetes and can cause swelling and fluids to leak into the macular area of the eye, affecting a person's vision. The condition is estimated to affected hundreds of thousands of people in Europe and rates are rising as more people develop diabetes.

Ozurdex joins a competitive market for DMO, with approved drugs in the EU including Novartis' Lucentis (ranibizumab). Bayer's fast-growing eye drug Eylea (aflibercept) has also been recommended by the Committee for Medicinal Products for Human Use (CHMP), although final approval is still pending.

Both these treatments are non-corticosteroids and have a wider DMO indication that does not require patients to have an artificial lens implant.

It is a similar situation in the US where both Eylea and Lucentis are approved in a standard DMO indication whereas Lucentis' approval covers its use in people with DMO who have an artificial lens implant or who are scheduled for cataract surgery.

Nevertheless the EU approval for Ozurdex is a positive step for Allergan whose ophthalmology business accounts for almost half of the company's sales, according to president of its operations in Europe, Africa and Middle East (EAME) Paul Navarre in a recent interview with PMLiVE.

The drug is already approved in the EU to treat adults with macular oedema caused by veins at the back of the eye becoming blocked and to treat adults with non-infectious uveitis at the back of the eye.

Article by
Thomas Meek

3rd September 2014

From: Sales



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