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The European Commission has extended the marketing authorization for Allergan’s dexamethasone 700-mcg intravitreal implant in applicator (Ozurdex) to treat adult patients with visual impairment due to diabetic macular edema (DME).
Irvine, CA-The European Commission has extended the marketing authorization for Allergan’s dexamethasone 700-mcg intravitreal implant in applicator (Ozurdex) to treat adult patients with visual impairment due to diabetic macular edema (DME).
The extended approval of the implant is for those who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroids therapy.
“Through Allergan’s efficient research and development 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 E.I. Pyott, Allergan’s board chairman and chief executive officer. “Following the positive opinion from the European Union’s Committee for Medicinal Products for Human Use just last month, we are particularly pleased . . . with this license extension for (the implant) in Europe.
“In addition to the recent FDA approval in the United States, we are able to offer another important treatment option to help preserve vision for certain patients with DME,” he continued.
The safety and efficacy of the implant in the management of patients with DME was assessed in the Macular Edema: Assessment of Implantable Dexamethasone in Diabetes (MEAD) clinical trial program. MEAD consisted of two multicenter, 3-year sham-controlled, masked, randomized clinical studies assessing the proportion of patients with 15 or more letters improvement in best-corrected visual acuity from baseline.
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