Alimera Sciences' Iluvien(TM) Phase 3 Studies for DME Pass Final DSMB Review Prior to October Readout
ATLANTA, April 8 /PRNewswire/ -- Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported that an independent Data Safety Monitoring Board (DSMB) has recommended the continuation of two pivotal Phase 3 clinical trials for the use of Iluvien(TM) in the treatment of diabetic macular edema (DME) under the current protocol, without change. The Board completed its final review of the currently available safety and efficacy data prior to the readout in October 2009. A DSMB provides an independent evaluation of all trial data to identify potential safety issues that might warrant modification or early termination of ongoing clinical studies.
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., Canada, Europe and India in support of a planned global registration filing. Safety and efficacy will be assessed after 24 months of follow-up, which will occur in October of this year.
"Alimera is pleased that the DSMB recommended the continuation of the FAME Study without change," said Alimera CEO Dan Myers. "We are looking forward to the last patient, last visit for the 24-month readout scheduled in October later this year."
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 October 2007 in two Phase 3 pivotal trials for the use of Iluvien in the treatment of DME conducted across the U.S., Canada, Europe and India.
Alimera also has entered into an exclusive worldwide agreement with Emory University to explore oxidative stress management -- specifically the reduction of reactive oxygen species (ROS) -- as a treatment strategy for ophthalmic diseases. Under this agreement, Alimera has acquired options to exclusive, worldwide licenses for two classes of nicotinamide adenine dinucleotide phosphate reduced form (NADPH) oxidase inhibitors, which Alimera is studying as potential treatments for conditions such as the dry form of age-related macular degeneration (AMD), particularly the late stage of this condition known as geographic atrophy. Alimera has exercised its option to acquire a license with respect to one of these classes of NADPH oxidase inhibitors.
CONTACT: Katie Brazel of Fleishman-Hillard, +1-404-739-0150,
katie.brazel@fleishman.com, for Alimera Sciences