Alimera receives FDA CRL for ILUVIEN NDA

Dec 24 2010

pSivida Corp. (NASDAQ:PSDV)(ASX:PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, including the investigational drug ILUVIEN® for the treatment of Diabetic Macular Edema (DME), today announced that Alimera Sciences, Inc, pSivida's collaborative partner, received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ILUVIEN. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form.

The NDA seeks approval to market ILUVIEN (fluocinolone acetonide intravitreal insert), an investigational, sustained drug delivery system that releases sub-microgram levels of fluocinolone acetonide for the treatment of DME. The ILUVIEN NDA was submitted 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 the CRL, the FDA asked for analyses of safety and efficacy data through month 36 of the FAME Study, including exploratory analyses in addition to those previously submitted in the NDA, to further assess the relative benefits and risks of ILUVIEN. Alimera has completed month 36 of the FAME Study and has reported that it is preparing the analyses that the FDA has requested. Alimera further reported that it has requested a meeting with the FDA to clarify the path to regulatory approval. The FDA did not ask for any new clinical studies in the CRL.

In the CRL, the FDA is also seeking additional information regarding controls and specifications concerning the manufacturing, packaging and sterilization of ILUVIEN, which Alimera reports it is in the process of compiling. Additionally, FDA indicated in the CRL that it had observed deficiencies in current good manufacturing practices (cGMP) during 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 reports that its third-party manufacturers are in the process of resolving these deficiencies.