"Alimera is pleased to share details of the Iluvien FAME study at this venue, perhaps the most important ophthalmology meeting of the year," said Dan Myers, Alimera president and CEO. "We believe the combination of low dose and long duration makes Iluvien a much anticipated potential treatment for DME."
Alimera submitted the Iluvien New Drug Application (NDA) to the U.S. Food and Drug Administration on June 30, 2010, and based on receipt of Priority Review status in August, anticipates a communication regarding the NDA by the end of the year. In addition, Alimera submitted a Marketing Authorization Application on July 5, 2010 to the Medicines and Healthcare products Regulatory Agency in the United Kingdom. Applications have also been submitted to regulatory agencies in Austria, France, Germany, Italy, Portugal and Spain.
DME, the primary cause of vision loss associated with diabetic retinopathy, a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage of diabetic retinopathy causes swelling in the retina, the condition is called DME. The onset of DME is painless and may go undetected by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period approximately 19 percent of people with diabetes studied were diagnosed with DME. As the population of people with diabetes increases, Alimera expects the annual incidence of diagnosed DME to increase, as well.About Iluvien Iluvien is an investigative, extended release intravitreal insert that Alimera is developing for the treatment of DME. Each Iluvien insert is designed to provide a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide. Iluvien is inserted in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The insertion device employs a 25-gauge needle, which allows for a self-sealing wound.