CRL for Alimera's Eye drug - Analyst Blog

Recently, Alimera Sciences Inc. (ALIM) faced a huge blow when the US Food and Drug Administration (FDA) refused to approve its lead candidate Iluvien in the present form due to insufficiency of data and issued a complete response letter (CRL). Moreover, the US regulatory body, while issuing the CRL, also cited deficiencies with third-party manufacturers of the eye drug. The companies are working to resolve the problems.

Alimera is looking to gain approval for Iluvien for the treatment of diabetic macular edema (DME). Diabetic macular edema is a disease affecting the macula, which is the part of the retina permitting central vision. It is the main cause of vision-loss associated with diabetic retinopathy. The disease is painless at its onset and may not be detected until the patient experiences either blurring of vision or acute loss of sight.

We remind investors that Alimera filed the new drug application (NDA) with the FDA in late June 2010. The US regulatory body agreed to review the application on a priority basis in late August this year. The FDA generally reviews those drugs on a priority basis, which offer major advances in treating diseases having no adequate therapy. Applications for priority review designated drugs are reviewed by the FDA within six months of submission instead of the usual ten months.

The application contained 24 months data from two phase III trials (known as the FAME Study) for Iluvien, conducted across   multiple sites in North America, Europe and India. The three-year study, involving 956 patients, was completed in October this year and evaluated the efficacy and safety of Iluvien, with a high and low dose, for the treatment of DME.

The FDA found the 24 month data insufficient for granting approval and asked Alimera to provide three year data from the FAME study. The agency, however, did not ask Alimera to conduct additional trials for the candidate which is a positive. Additional trials would have pushed up the research & development costs significantly.

Iluvien is also under review in the UK. In July 2010, Alimera submitted the Marketing Authorization Application (MAA) for Iluvien to the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK. The company is also seeking approval for the candidate in Austria, France, Germany, Italy, Portugal and Spain. We note that all the filings include data, acquired over a 24-month period, from the FAME Study.

Alimera Sciences, based in Alpharetta, Georgia, currently has a Zacks #3 Rank, which translates into a short-term ‘Hold' rating.