Alimera to present Iluvien Phase 3 clinical trial data at AAO annual meeting

Oct 12 2010

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.

Source: Alimera Sciences, Inc.