FDA Approves Revised Indication for Diabetic Macular Edema Treatment

The dexamethasone intravitreal implant, Ozurdex, is now indicated to treat all patients with diabetic macular edema (DME), Allergan Inc announced today.

The FDA previously expanded its approval of Ozurdex 0.7 mg to treat adult DME patients who have an artificial lens implant or are scheduled for cataract surgery. Based on its ongoing review of efficacy and safety data, the agency has now revised the drug’s approval for use in the general DME patient population.

“Allergan is committed to developing innovative treatment options that address unmet patient needs, and retinal diseases such as DME are extremely difficult to manage,” said Scott M. Whitcup, MD, Executive Vice President of Research and Development and Chief Scientific Officer for Allergan, in a press release. “We are pleased that the updated indication supports the use of Ozurdex to help improve vision for more patients with DME.”

More than 560,000 Americans currently experience DME, an eye condition that occurs in patients with type 1 or type 2 diabetes and causes blurred vision, vision loss, and eventual blindness. As a sustained-release biodegradable steroid implant, Ozurdex suppresses the inflammation that plays a key role in DME, Allergan noted.

Ozurdex was originally approved in June 2009 for the treatment of macular edema following branch retinal vein occlusion or central retinal vein occlusion, and then expanded the following year for the treatment of non-infectious uveitis affecting the posterior segment of the eye.

According to Allergan, data from the 3-year Macular Edema: Assessment of Implantable Dexamethasone in Diabetes (MEAD) study demonstrated Ozurdex’s long-term efficacy in treating DME without the need for monthly injections, which formed the basis for the drug’s new DME indication.