FDA extends indications for Ozurdex

Allergan reports that the U.S. FDA has approved the intravitreal dexamethasone implant for all patients with diabetic macular edema (DME).

Originally approved in June for DME in pseudophakic patients, the FDA agreed to extend approval to the general DME patient population, based on a review of ongoing trials demonstrating efficacy and safety.

The safety and efficacy of Ozurdex was assessed in the MEAD (Macular Edema: Assessment of Implantable Dexamethasone in Diabetes) clinical trial program, which consisted of two multicenter, three-year, sham-controlled, masked, randomized clinical studies assessing the proportion of patients whose BCVA improved by 15 or more letters from baseline.

The Ozurdex implant is also indicated for macular edema following branch retinal vein occlusion or central retinal vein occlusion and for treating non-infectious, posterior uveitis.