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Allergan receives recommendation for Ozurdex licence extension
Allergan has been granted a recommendation for the proposed extension of its biodegradable implant Ozurdex's licence, allowing it to be used as a non-infectious uveitis therapy.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that the product's marketing authorisation status be broadened to include the treatment of inflammation of the posterior segment of the eye.
Ozurdex, which is already licensed for treating macular oedema in patients with retinal vein occlusion, functions by delivering an extended release of the anti-inflammatory corticosteroid dexamethasone for up to six months.
The CHMP granted the position opinion based on data from a phase III trial showing its effectiveness in improving vision among patients.
Douglas Ingram, president for Allergan in Europe, Africa and the Middle East, said: "This is a crucial step in the process to bring this innovative anti-inflammatory treatment option to physicians and their patients suffering from uveitis."
Last month, Allergan announced the re-appointment of chairman and chief executive officer David Pyott as company president, following the departure of F Michael Ball to Hospira.
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