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Allergan's Ozurdex approved by EMA

Allergan has announced the European approval of Ozurdex, the first drug authorised in the region for the treatment of macular oedema due to RVO

Allergan has announced the European Medicines Agency's (EMA) approval of Ozurdex (dexamethasone), the first treatment authorised in Europe for the treatment of macular oedema due to retinal vein occlusion (RVO).

"We are delighted that the European Medicines Agency has granted marketing authorisation for Ozurdex," said David Endicott, president, Allergan, Europe, Africa and the Middle East.

"As a leading company in ophthalmology, Allergan are pleased to enter the retina market and to provide physicians and their patients with the first European-licensed drug treatment for macular oedema following retinal vein occlusion."

Macular oedema is an eye condition, involving excessive build up of fluid in the retina and thickening of the macula – a spot near the centre of the retina. It can be caused by RVO – the blockage of a vein in the retina which leads to an inflammatory response.

The condition results in impaired vision, with permanent visual loss possible if swelling persists over a prolonged period of time.

Ozurdex works by controlling the build up of fluid and reducing the inflammation around the blockage. It is the first treatment of its kind, using a biodegradable implant of dexamethasone that is administered into the eye with a specially designed single use injection.

"Until the approval of Ozurdex, ophthalmologists had limited treatment options to offer patients with RVO," said associate professor Winfried Amoaku from the University of Nottingham.

"The availability of a licensed, effective treatment for both BRVO (branch retinal vein occlusion) and CRVO (central retinal vein occlusion) that offers patients long-lasting vision improvement from a single intravitreal injection is a significant advance for clinicians and their patients."

Allergan has said it plans to launch the therapy across Europe starting in the third quarter of 2010.

28th July 2010

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