Allergan Says FDA Approves Revised Indication For OZURDEX

(RTTNews) - Allergan, Inc. (AGN) said the U.S. Food and Drug Administration has approved OZURDEX (dexamethasone intravitreal implant) 0.7 mg, a sustained-release biodegradable steroid implant, for the treatment of diabetic macular edema or DME.

OZURDEX was originally approved in June as a treatment for DME in adult patients who have an artificial lens implant or who are scheduled for cataract surgery.

Based on ongoing review of clinical data demonstrating efficacy and safety, the FDA has now approved OZURDEX for use in the general DME patient population.

DME currently impacts more than 560,000 Americans. It is an eye condition that can occur in people with diabetes and causes fluid to leak into the part of the eye where focusing occurs, causing blurred vision, vision loss and eventual blindness.