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Enrollment Begins on Human PK Study for Medidur(TM) FA
Date:8/22/2007

ATLANTA, Aug. 22 /PRNewswire-FirstCall/ -- Alimera Sciences, a privately held ophthalmic pharmaceutical company, and pSivida Limited (Nasdaq: PSDV, ASX: PSD, Xetra: PSI) today announced that enrollment has begun for the first human pharmacokinetic (PK) study of fluocinolone acetonide (FA) in Medidur(TM), the companies' investigational product for the treatment of diabetic macular edema (DME).

Medidur is a tiny insert, injected intra-vitreally during an in-office procedure, which is being studied as a way to deliver a very low dose of fluocinolone acetonide (FA), a corticosteroid, to the retina for up to three years as a treatment for DME. Medidur FA is currently in a Phase III global clinical trial, the FAME(TM) (Fluocinolone Acetonide in Diabetic Macular Edema) Study that will follow approximately 900 patients in the U.S., Canada, Europe and India for three years with safety and efficacy assessed at two years. Enrollment for this study has currently exceeded 750 patients.

This PK study is designed to support the FAME trial by providing pharmacokinetic/pharmacodynamic correlation data from DME patients. Sixteen patients are planned to be enrolled in this three-year, open label study. Samples of blood and aqueous humor (the fluid in the front of the eye) will be periodically taken to assess systemic and anterior chamber drug levels, respectively.

"Enrolling the same population in this study as in our FAME trial for DME will provide another important opportunity to learn more about the effect of FA on various aspects of this condition, as well as assess systemic drug levels," said Ken Green, PhD, Chief Scientific Officer for Alimera. "This study will also provide information on the location of Medidur
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SOURCE Alimera Sciences Inc.
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