Alimera Sciences (ALIM) recently submitted Marketing Authorization Application (MAA) for Iluvien (fluocinolone acetonide intravitreal insert) to the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK. Iluvien is being studied to treat diabetic macular edema (DME).
Alimera’s MAA submission in the UK comes after it filed its New Drug Application (NDA) with the US Food and Drug Administration (FDA) in late June 2010. It is expected that, once approved, Iluvien will be utilized by medical practitioners as an alternative to the multiple injections of corticosteroids.
At present, Alimera is conducting two clinical trials in the phase III stage (known as the FAME Study) for Iluvien at multiple sites in North America, Europe and India. These trials are designed to gauge the efficacy and safety of Iluvien, with a high and low dose, for the treatment of DME. The study is expected to be completed later in 2010. Alimera’s MAA submission includes low dose data, acquired over a 24-month period, from the FAME Study.
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 detects either blurring of vision or acute loss of sight.
Iluvien is an extended-release, investigative, intravitreal insert for the treatment of DME.
Alpharetta, Georgia-based, Alimera Sciences is a biopharmaceutical company with a focus on the research and commercialization of prescription ophthalmic pharmaceuticals. It specializes in conditions affecting the retina.
Read the full analyst report on “ALIM”
Zacks Investment Research
