Alimera Sciences' Iluvien(TM) Phase 3 Studies for DME Pass Final DSMB Review Prior to October Readout
These clinical trials, known collectively as the FAME(TM) Study (Fluocinolone Acetonide in Diabetic Macular Edema), consist of two 36-month, doublemasked, randomized, multi-center trials in the U.S.,
"Alimera is pleased that the DSMB recommended the continuation of the FAME Study without change," said Alimera CEO
Iluvien is an intravitreal insert being developed for the treatment of DME. DME is a disease of the retina, which affects individuals with diabetes and can lead to severe vision loss and blindness. Each Iluvien insert is designed to provide a sustained therapeutic effect, up to 36 months for the low dose and up to 24 months for the high dose. Iluvien is inserted into the patient's eye with a 25-gauge needle, which allows for a self-sealing wound. This insertion is very similar to an intravitreal injection, a procedure commonly employed by retinal specialists.
Currently, nearly 24 million people, or 8 percent of the population, in the U.S. have diabetes. Over time, all diabetics are at risk of developing some form of diabetic retinopathy, an ophthalmic condition of diabetes. In the U.S., diabetic retinopathy causes approximately 12,000 to 24,000 new cases of blindness each year, making diabetes the leading cause of new cases of blindness in adults aged 20 to 74. Based on published data, Alimera estimates that there are as many as 300,000 new cases of DME each year and 1,000,000 people have DME. There are no ophthalmic drug therapies currently approved by the U.S. Food and Drug Administration for the treatment of DME.
About Alimera Sciences, Inc.
Alimera Sciences is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Presently the company is focused on diseases affecting the back of the eye, or retina. Its most advanced product candidate is Iluvien(TM), which is being developed for the treatment of diabetic macular edema, or DME. DME is a disease of the retina, which affects individuals with diabetes and can lead to severe vision loss and blindness. Under one protocol, enrollment was completed in
Alimera also has entered into an exclusive worldwide agreement with
SOURCE Alimera Sciences, Inc.