FDA clears Iluvien for DME

Following resolution of safety concerns, the U.S. FDA has approved Iluvien for diabetic macular edema (DME). Alimera Sciences expects to begin selling Iluvien in the United States in early 2015.

The sustained release intravitreal implant is approved for patients previously treated with corticosteroids who did not have a clinically significant rise in intraocular pressure. Injected into the posterior segment, Illuvien provides a therapeutic effect for up to 36 months.

"We are very excited with this news from the FDA and thank the many people who contributed to this outcome and believed in Iluvien, including the retinal specialists, clinical site personnel, reading centers, and the many patients and their caregivers for helping us bring this long-term treatment to people in the U.S. with DME," said Dan Myers, president and chief executive officer of Alimera. "The approval of Iluvien under this broader label brings a DME treatment to the U.S. that lasts years, not months, after a single injection and greatly expands the addressable market opportunity in the U.S."

The FDA initially rejected Alimera’s application due to concerns about the drug’s safety profile. The company subsequently included information on commercial experience with Iluvien in Europe.

In a phase 3 clinical study of Iluvien, the most frequently reported adverse drug reactions included cataract development and increased ocular pressure.

Iluvien is approved in 10 European countries, including the United Kingdom, France and Germany.