CHMP recommends extended indication for Ozurdex for DME - Allergan

Allergan, Inc. has announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended extending the Marketing Authorization for Ozurdex (dexamethasone 700 mcg intravitreal implant in applicator) to treat adult patients with vision loss 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-corticosteroid therapy.

DME is a condition that affects approximately 7% of patients with diabetes and is the leading cause of sight loss in patients with diabetes. The Ozurdex implant uses the proprietary and innovative Novadur solid polymer delivery system - a biodegradable implant that releases medicine over an extended period of time - to suppress inflammation, which plays a key role in the development of DME.