ATLANTA, Oct. 12, 2010 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc., (Nasdaq:ALIM) ("Alimera"), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that data from its Phase 3 (FAME™) clinical trials for Iluvien® will be presented this month at the annual meeting of the American Academy of Ophthalmology (AAO) in Chicago. Iluvien is Alimera's investigational intravitreal insert being studied for diabetic macular edema (DME). The presentation, by Baruch Kuppermann, M.D., Ph.D, professor and chief of the Retina Service at University of California, Irvine, is slated for 4:19 p.m., Saturday, October 16, during the Retina 2010 subspecialty day program.
Alimera has conducted two Phase 3 pivotal clinical trials (collectively known as the FAME Study) for Iluvien involving 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of Iluvien with two doses, a high and low dose, in the treatment of DME.
The data in Dr. Kuppermann's presentation, titled "Treatment of Diabetic Macular Edema with a Fluocinolone Implant: Results of the FAME Study," were derived from the study's 24-month read-out, which indicates that patient vision continues to improve significantly at 24 months.
During the FAME Study, a statistically significant difference in best corrected visual acuity versus control was seen by three weeks, and this difference was maintained through month 24. Alimera expects to present the complete 36-month dataset in the near future.
"These are exciting times for retinal specialists, given the increased focus on back of the eye therapies," said Dr. Kuppermann. "The Iluvien data is particularly noteworthy as it shows that a significant percentage of patients who receive the insert experience long-term vision improvement for up to 24 months."
In other AAO annual meeting activities, Alimera will be present at the Tabletop Exhibit at McCormick Place, Lakeside, Level 2, Hall E, during the Retina subspecialty day program, and at booth #4307 on the main AAO exhibit floor in the South Building, Level 3, Hall A.
"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.
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.
About Alimera Sciences, Inc.
Alimera Sciences, Inc., based in Alpharetta, Georgia, is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Presently, Alimera is focused on diseases affecting the back of the eye, or retina. Its advanced product candidate, Iluvien, is an intravitreal insert containing fluocinolone acetonide, a non-proprietary corticosteroid with demonstrated efficacy in the treatment of ocular disease. Iluvien is in development for the treatment of DME, a disease of the retina that affects individuals with diabetes and can lead to severe vision loss and blindness.
Forward Looking Statements
This press release contains "forward-looking statements," within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, Alimera's future results of operations and financial position, business strategy and plans and objectives of management for Alimera's future operations. Words such as "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "likely," "will," "would," "could," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The events and circumstances reflected in Alimera's forward-looking statements may not occur and actual results could differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, delay in or failure to obtain regulatory approval of Alimera's product candidates, uncertainty as to Alimera's ability to commercialize, and market acceptance of, its product candidates, the extent of government regulations, uncertainty as to relationship between the benefits of Alimera's product candidates and the risks of their side-effect profiles, dependence on third-party manufacturers to manufacture Alimera's product candidates in sufficient quantities and quality, uncertainty of clinical trial results, limited sales and marketing infrastructure, as well as other factors discussed in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Alimera's quarterly reports on Form 10-Q for the quarters ended March 31, 2010 and June 30, 2010, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov. Additional factors may also be set forth in those sections of Alimera's quarterly report on Form 10-Q for the quarter ended September 30, 2010 to be filed with the SEC.
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