Alimera Sciences, Inc. (ALIM), a biopharmaceutical company, said Thursday that the U.S. Food and Drug Administration rejected its New Drug Application for the investigational drug ILUVIEN, dragging down the company's shares by 40% in after hours trade on the Nasdaq.
The application seeks the approval to market ILUVIEN, an investigational, sustained drug delivery system that releases sub-microgram levels of fluocinolone acetonide for the treatment of diabetic macular edema. Alimera is collaborating with pSivida Corp. (PSDV) in the development of ILUVIEN. pSivida shares are also down by about 40% in after hours.
Alimera submitted the ILUVIEN NDA to the FDA on June 29, 2010 with safety and efficacy data through month 24 of the FAME Study. The FDA granted the NDA Priority Review status on August 30, 2010.
In its Complete Response Letter, the FDA asked for analyses of the safety and efficacy data through month 36 of the FAME Study, including exploratory analyses in addition to those previously submitted to the FDA, to further assess the relative benefits and risks of ILUVIEN.
No new clinical studies were requested in the CRL.
Alimera has completed month 36 of the study and is preparing the analyses the FDA requested. The FDA is also seeking additional information regarding controls and specifications concerning the manufacturing, packaging and sterilization of ILUVIEN, which Alimera is in the process of compiling.
The FDA also said it had observed deficiencies in current good manufacturing practices during its facility inspections of two of Alimera's third-party manufacturers, which were completed in August and September of 2010, and that all facilities and controls will need to comply with cGMP. Alimera's third-party manufacturers are in the process of resolving these deficiencies.
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