EU extends Ozurdex indication for Diabetic Macular Edema- Allergan

Allergan, Inc. has announced that the European Commission has extended the Marketing Authorization for Ozurdex (dexamethasone 700 mcg intravitreal implant in applicator) 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.

The safety and efficacy of Ozurdex in the management of patients with DME was assessed in the MEAD (Macular Edema: Assessment of Implantable Dexamethasone in Diabetes) clinical trial program. MEAD consisted of two multi-center 3-year sham-controlled, masked, randomized clinical studies assessing the proportion of patients with 15 or more letters improvement in best-corrected visual acuity (BCVA) from baseline.

Developed for the treatment of retinal disease, the Ozurdex implant uses the proprietary 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. Ozurdex is already available throughout the European Union as a treatment licensed for Macular Edema in patients with Retinal Vein Oocclusion (RVO) and for inflammation of the posterior segment of the eye characterized as non-infectious uveitis.