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,
"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
For more information on Alimera Sciences, visit http://www.alimerasciences.com.
|SOURCE Alimera Sciences Inc.|
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