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Alimera Reports Results From the Three-Month Interim Readout of the Human PK Medidur(TM) FA Study
Date:6/26/2008

ATLANTA, June 26 /PRNewswire/ -- Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported the interim month three safety and efficacy results from the first human pharmacokinetic (PK) study of Medidur(TM) FA, which Alimera Sciences intends to market under the tradename Iluvien(TM), if approved by the U.S. Food and Drug Administration.

This 36-month, open-label Phase 2 study, running concurrently with the pivotal Phase 3 FAME(TM) Study (Fluocinolone Acetonide in Diabetic Macular Edema), is designed primarily to assess systemic exposure of the corticosteroid, fluocinolone acetonide (FA), after administration of Iluvien in diabetic macular edema (DME) patients. Secondarily, the study is designed to provide information on the safety and efficacy of Iluvien in a DME population. A total of 37 subjects were enrolled in this trial, 20 patients on the low dose (an approximate 0.23 microgram per day dose) of Iluvien, and 17 patients on the high dose (an approximate 0.45 microgram per day dose) with the same inclusion/exclusion criteria as the ongoing Phase 3 FAME Study.

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 24 months for the low dose and up to 36 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.

This three-month interim readout from the PK Study indicated 20 percent of the low dose patients and 18 percent of the high dose patients showed an improvement in best-corrected visual acuity
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SOURCE Alimera Sciences, Inc.
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