Industry News — Clinical Updates
Allergan Gains FDA Approval for Ozurdex Use in Certain DME Patients
Allergan, Inc, (Irvine, CA) has announced that the US Food and Drug Administration (FDA) has approved the Ozurdex 0.7 mg dexamethasone intravitreal implant as a treatment option for pseudophakic and phakic diabetic macular edema (DME) patients. The Ozurdex indication makes it the first corticosteroid approved for use in certain DME patients.
The FDA approved Ozurdex for these patient groups based on the results of the Macular Edema: Assessment of Implantable Dexamethasone in Diabetes (MEAD) study. MEAD includes 2 multicenter 3-year sham-controlled, masked, randomized clinical studies assessing the proportion of patients with 15 or more letters of improvement in best-corrected visual acuity (BCVA) from baseline.
The most common adverse events in the study included cataracts and elevated intraocular pressure (IOP). An increase in mean IOP was seen with each treatment cycle, and the mean IOP generally returned to baseline between treatment cycles.
Updated June 30, 2014