Allergan's Ozurdex approved for DME in Europe

Allergan (NYSE: AGN) revealed today that the European Commission has extended the marketing authorization for Ozurdex (dexamethasone 700mcg intravitreal implant in applicator).

The drug, which has previously been approved in the USA and Europe as a treatment for macular edema, is now cleared to treat adult patients with visual impairment due to diabetic macular edema (DME) who are pseudophakic (have an artificial lens implant), or who are considered insufficiently responsive to, or unsuitable for non-corticosteroids therapy.DME is a common complication with diabetes and is the leading cause of sight loss in patients with diabetes.

“Through Allergan’s efficient R&D investment, we are able to continually bring forth innovative new treatment options for physicians and their patients while delivering value to our stockholders,” said David Pyott, chairman and chief executive of Allergan, which is fending off a hostile bid from Valeant (The Pharma Letters passim). “Following the positive opinion from the European Union’s Committee for Medicinal Products for Human Use just last month, we are particularly pleased that with this license extension for Ozurdex in Europe, in addition to the recent FDA approval in the USA, we are able to offer another important treatment option to help preserve vision for certain patients with DME,” he added.