ATLANTA, May 13, 2011 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq:ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced the resubmission on May 12, 2011 of its New Drug Application for the investigational drug ILUVIEN® to the U.S. Food and Drug Administration (FDA). The resubmission addresses questions raised in the Complete Response Letter (CRL) received in December 2010.
According to the FDA's classification, this will be a Class 2 resubmission. Under the Prescription Drug User Fee Act (PDUFA), FDA review of a Class 2 resubmission is expected to be completed within a six-month period beginning on the date that the resubmission is received.
This resubmission addresses the FDA's request for analyses of the safety and efficacy data through month 36 of Alimera's FAME Study, and includes the data from the subgroup population that was presented last week at the 2011 Association for Research in Vision and Ophthalmology Annual Meeting. In addition, the resubmission includes further information regarding controls and specifications about the manufacturing, packaging and sterilization of ILUVIEN, which was requested by the FDA.
"We believe that the resubmission package sent to the FDA will demonstrate the safety and efficacy of ILUVIEN and address the FDA's additional issues," said Dan Myers, Alimera's president and CEO. "We look forward to working with the FDA for a prompt review and response."
In the CRL, the FDA also indicated that it had observed deficiencies in current good manufacturing practices (cGMP) during its facility inspections of two of Alimera's third-party manufacturers. Alimera believes the deficiencies have been resolved and no further action is required because the FDA has issued letters to both of these third-party manufacturers indicating that the inspections are now closed.
About Alimera Sciences, Inc.
Alimera Sciences, Inc., based in Alpharetta, Georgia, is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Presently, Alimera is focused on diseases affecting the back of the eye, or retina. Its advanced product candidate, ILUVIEN, is an investigational intravitreal insert containing fluocinolone acetonide (FAc), a non-proprietary corticosteroid with demonstrated efficacy in the treatment of ocular disease. ILUVIEN is in development for the treatment of diabetic macular edema (DME), a disease of the retina that affects individuals with diabetes and can lead to severe vision loss and blindness.