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Home Industry News Allergan receives CHMP backing for new Ozurdex approval

Allergan receives CHMP backing for new Ozurdex approval

29th July 2014

Allergan has announced that Europe's Committee for Medicinal Products for Human Use (CHMP) has recommended its product Ozurdex for approval in a new indication.

The European Medicines Agency committee has issued a positive opinion on Ozurdex's use as a therapy for adults with vision loss due to diabetic macular oedema who are pseudophakic or who are considered insufficiently responsive to or unsuitable for non-corticosteroid therapy.

An intravitreal implant-based treatment, the product has already shown its potential benefits for this patient group in clinical studies. Following this CHMP endorsement, a final decision from the European Commission will be issued in the next few months.

Ozurdex is already approved in Europe as a treatment licensed for macular oedema in patients with retinal vein occlusion and for inflammation of the posterior segment of the eye characterised as non-infectious uveitis.

David Pyott, Allergan's chairman of the board and chief executive officer, said: "Our ability to advance research and development programmes allows us to continually bring forth new treatment options for physicians and their patients, while delivering value to our stockholders."

Earlier this month, the company reported a 15.9 percent year-on-year increase in total product net sales during the second quarter of 2014.ADNFCR-8000103-ID-801738232-ADNFCR

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