Recently, Alimera Sciences’ (ALIM) pipeline received a boost when the US Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for its lead candidate, Iluvien. Furthermore, the agency has decided to review the application on a priority basis. The company is looking to gain approval for Iluvien for the treatment of diabetic macular edema (DME).
The company filed the NDA with the FDA in late June 2010. The US regulatory authority 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. Based on that criterion, a response from the FDA should be out in the fourth quarter of 2010.
The candidate 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. Alimera intends to file an application seeking marketing approval for the eye drug in Canada in September this year.
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.
At present, Alimera is conducting two phase III trials (known as the FAME Study) for Iluvien at multiple sites in North America, Europe and India. These trials, involving 956 patients, are designed to gauge the efficacy and safety of Iluvien, with a high and low dose, for the treatment of DME. . We note that all the filings include low dose data, acquired over a 24-month period, from the FAME Study. It is expected that, once approved, Iluvien will be utilized by medical practitioners as an alternative to the multiple injections of corticosteroids.
Alimera Sciences, based in Alpharetta, Georgia, currently has a Zacks #3 Rank, which translates into a short-term Hold rating.