Industry News — Clinical Updates

FDA Approves Revised Indication for Ozurdex for Diabetic Macular Edema

The US Food and Drug Administration (FDA) has approved Ozurdex (dexamethasone intravitreal implant; Allergan, Inc, Irvine, CA) 0.7 mg for treatment of DME in the general patient population. This is an expansion from the FDA approval in June of Ozurdex for treating DME in pseudophakic and phakic adult patients.

The FDA’s approval for the general DME population is based on the MEAD study which demonstrated long-term efficacy of Ozurdex in the treatment of DME without the need for monthly injections.

Ozurdex is also indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) and for the treatment of noninfectious uveitis affecting the posterior segment.

Updated September 29, 2014