Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, has received a Complete Response Letter (CRL) for the New Drug Application (NDA) for Iluvien from the US Food and Drug Administration (FDA).

Identifying concerns regarding the benefit to risk and safety profiles of Iluvien, the FDA stated that the NDA could not be approved in its present form.  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 FDA suggested that a meeting with the Dermatologic and Ophthalmic Drugs Advisory Committee may be of assistance in addressing the deficiencies identified above and providing advice whether a patient population can be identified in which the benefits of the drug product might outweigh the risks. In a separate written communication from the staff of the FDA, Alimera was notified that an Advisory Committee meeting would be convened on January 27, 2014.

In the CRL, the FDA also referenced deficiencies at the facility where Iluvien is manufactured. Alimera does not believe that these deficiencies will affect its European commercial supply.

"The FDA's decision not to approve Iluvien at this time is disappointing not only to us, but also to retinal specialists and DME 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 US for Iluvien," said Dan Myers, president and chief executive officer of Alimera. "We remain excited about Europe, however, where we have aligned our energy and resources to support the expansion of our business there. Our current traction in the countries in which Iluvien has already been approved, coupled with our continued pursuit of further country approvals, should position us well for future growth, irrespective of the US outcome."

Alimera's commercial focus is on Europe, where the product is approved and commercially available in the United Kingdom and Germany and slated to launch in France early next year. Iluvien is also approved in Austria, Portugal and Spain and pending approval in Italy. In addition, Alimera has filed with the Medicines and Healthcare Products Regulatory Agency in the United Kingdom (UK) as the Reference Member State for 10 additional European Union country approvals through the Mutual Recognition Procedure.

Iluvien (190 micrograms intravitreal implant in applicator) is a sustained release intravitreal implant used to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each Iluvien implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc). Iluvien is injected in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound. In the FAME Study, the most frequently reported adverse drug reactions included cataract development and increased ocular pressure. Iluvien has not been approved for sale in the US.

Alimera Sciences, Inc., headquartered in Alpharetta, Georgia, is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals.