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Alimera Sciences Begins Pilot Study to Assess Safety and Efficacy of Iluvien(TM) in Patients With Bilateral Geographic Atrophy Due to AMD
Date:12/11/2008

ATLANTA, Dec. 11 /PRNewswire/ -- Alimera Sciences Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported that enrollment has begun for a pilot study to assess the safety and efficacy of Iluvien(TM) in patients with bilateral geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

The pilot study will compare two doses of Iluvien (0.23 and 0.45 micrograms per day) to sham injection in patients with bilateral geographic atrophy secondary to AMD. The change from baseline in size of geographic atrophy will be assessed over time.

"The impetus for this study was the results of experiments conducted in two animal models of retinal degenerations. In both of these models, a miniaturized version of Iluvien demonstrated protective effects on the spontaneous degeneration which occurs in these animals," said Raymond Iezzi, M.D., M.S., Scientific Director, Ligon Research Center of Vision, Assistant Professor of Ophthalmology, Vitreoretinal Service, Kresge Eye Institute, Wayne State University School of Medicine.

"These results were considered compelling enough to warrant a human study, especially for a condition for which there is no approved treatment," added Dr. Iezzi.

Iluvien, a tiny, intravitreal insert, is currently being studied in the FAME Phase III clinical trial as a way to deliver a very low dose of fluocinolone acetonide, a corticosteroid, to the retina for up to three years as a treatment for diabetic macular edema (DME). An eye care professional, using a proprietary 25-gauge inserter, places Iluvien into the vitreous in a minimally invasive, outpatient procedure.

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, with a combined total enrollment of 956 patients.

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 the exclusive option to license compounds, which are nicotinamide adenine dinucleotide phosphate reduced form (NADPH) oxidase inhibitors, as potential treatments for conditions such as the dry form of 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.

For more information on Alimera Sciences, visit http://www.alimerasciences.com.


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SOURCE Alimera Sciences Inc.
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