CHMP recommends label expansion for Ozurdex


The EMA's Committee for Medicinal Products for Human Use (CHMP) issues a positive opinion recommending approval for the use of Allergan's (AGN) Ozurdex (dexamethasone 700 mcg intravitreal implant in applicator) as a treatment for vision loss in patients with diabetic macular edema who have an artificial lens implant and who do are responding sufficiently to or are unsuitable for non-corticosteroid therapy.

Ozurdex's current labeling in Europe covers macular edema in patients with retinal vein occlusion and inflammation of the posterior segment of the eye characterized as non-infectious uveitis.

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