Tuesday, July 29, 2014

Allergan gets EU recommendation on new use of eye drug

Fri Jul 25, 2014 12:33pm EDT

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(Reuters) - Allergan Inc, known best for its Botox wrinkle treatment, said on Friday that European Union regulators had recommended use of its eye drug Ozurdex be extended to treat patients with diabetic macular edema.

The European Medicines Agency's recommendation for approval of the extension of the drug's use comes one month after the U.S. Food and Drug Administration granted this broader use.

The extension involves allowing Allergan's sustained-release biodegradable steroid implant to be used to treat diabetic macular edema in adult patients who have an artificial lens implant or are unresponsive or unsuitable for non-corticosteroid therapy.

The drug is approved to treat macular edema and non-infectious ocular inflammation.

A final decision from the European Commission on the use is expected within a few months, the company said.

Allergan is fighting a hostile bid from Valeant Pharmaceuticals International Inc.

(This version of the story corrects patient group in third paragraph to remove reference to cataract surgery)

(Reporting by Caroline Humer; Editing by Nick Zieminski)

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