FDA delays approval of new drug application for Iluvien

Citing concerns about safety and manufacturing standards, the U.S. Food and Drug Administration has notified Alimera Sciences that it cannot approve the company’s new drug application for the Iluvien intravitreal implant.

In a complete response letter to Alimera, the FDA identified concerns about the benefit-to-risk and safety profiles of Iluvien (sustained-release fluocinolone acetonide), according to a news release from Alimera.

“To address the clinical and statistical deficiencies identified, the FDA indicated that results from a new clinical trial would need to be submitted, together with at least 12 months of follow-up for all enrolled patients,” the release said.

The FDA also outlined deficiencies at the facility where Iluvien is manufactured.

“Alimera does not believe that these deficiencies will affect its European commercial supply,” the release said.

In a separate letter, FDA staff notified Alimera that an advisory committee meeting will be convened on Jan. 27, 2014.

“The FDA suggested that a meeting with the Dermatologic and Ophthalmic Drugs Advisory Committee may be of assistance in addressing the deficiencies identified … and providing advice whether a patient population can be identified in which the benefits of the drug product might outweigh the risks,” the release said.

Alimera will cooperate with the advisory committee, Dan Myers, president and CEO of Alimera, said in the release.

“The FDA’s decision not to approve Iluvien at this time is disappointing not only to us, but also to retinal specialists and [diabetic macular edema] patients in the U.S., but we will continue to work with the FDA, through the advisory committee, to determine whether there is a path forward in the U.S. for Iluvien,” Myers said.

Iluvien is approved and commercially available in the United Kingdom and Germany and is scheduled for launch in France in early 2014. It is also approved in Austria, Portugal and Spain and is awaiting approval in Italy.