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Enrollment Complete in Pivotal Phase III Trial of Medidur(TM)FA for Diabetic Macular Edema

09 Oct 2007

Sciences Inc., a privately held ophthalmic pharmaceutical company, and pSivida Limited announced today that enrollment is complete for the FAME™ Study of Medidur™ FA for the treatment of Diabetic Macular Edema

ATLANTA, GA, USA | October 8, 2007 | Alimera Sciences Inc., a privately held ophthalmic pharmaceutical company,

and pSivida Limited (NASDAQ:PSDV, ASX:PSD, Xetra:PSI), announced today that enrollment is complete for the FAME™ (Fluocinolone Acetonide in Diabetic Macular Edema) Study of Medidur™ FA for the treatment of Diabetic Macular Edema.
FAME is a double masked, randomized, multi-center study that is following over 900 patients in the U.S., Canada, Europe, and India, for 36 months with safety and efficacy assessed at two years. Alimera Sciences and pSivida are jointly developing Medidur FA under a collaborative research and development agreement.

“Alimera Sciences is very excited to have completed enrollment in the FAME Study as this brings us closer to taking Medidur FA, the next generation of retinal drug delivery, to market and to our ultimate goal of delivering treatments that enrich patients’ quality of life,” said Alimera CEO Dan Myers.

Medidur, a tiny, injectable insert, is being studied as a way to deliver fluocinolone acetonide, a corticosteroid, to the retina for up to three years as a treatment for diabetic macular edema (DME). Using a proprietary 25 gauge injector system, an eye care professional injects the Medidur insert into the vitreous through a minimally invasive procedure in an outpatient setting.

“This marks an important milestone for the Company in our profit sharing collaboration with Alimera. We are very pleased at the continued development of Medidur FA, based on our technologies that have already been approved for two back of the eye diseases. We are optimistic that Medidur FA will offer a solution to the large market we see for this product,” said pSivida Limited Managing Director, Dr Paul Ashton.

Diabetic retinopathy (DR), a complication of diabetes mellitus, is the leading cause of blindness in the working-age population of developed countries. At any time during progression of diabetic retinopathy, patients can develop DME which involves retinal thickening of the macular area. More than 500,000 people live with DME in the United States and this number is expected to exceed 700,000 by the year 2010. Currently there are no FDA approved drug treatments for DME.

About Alimera Sciences Inc.

Alimera Sciences Inc., an Atlanta, GA. based venture backed company, specializes in the development and commercialization of prescription ophthalmology pharmaceuticals. Founded by an executive team with extensive development and revenue growth expertise, Alimera Sciences products are focused on improving the delivery of therapeutic agents to enhance patients’ lives and strengthen physicians’ ability to manage ocular conditions. Alimera is currently conducting a phase III clinical trial of fluocinolone acetonide in the Medidur™ drug delivery system for the treatment of diabetic macular edema. For more information, please visit www.alimerasciences.com

About pSivida Limited

pSivida, a Boston, MA. based global drug delivery company, is committed to the biomedical sector. Retisert® is FDA approved for the treatment of uveitis. Vitrasert® is FDA approved for the treatment of AIDS-related CMV Retinitis. Bausch & Lomb own the trademarks Vitrasert® and Retisert®. pSivida has licensed the technologies underlying both of these products to Bausch & Lomb. The technology underlying Medidur™ for diabetic macular edema is licensed to Alimera Sciences and is in Phase III clinical trials. pSivida has a worldwide collaborative research and license agreement with Pfizer Inc. for other ophthalmic applications of the Durasert™ technology which underpins the Medidur product.

pSivida owns the rights to develop and commercialize a modified form of silicon (porosified or nano-structured silicon) known as BioSilicon™, which has applications in drug delivery, wound healing, orthopedics, and tissue engineering. The most advanced BioSilicon™ product, BrachySil™ delivers a therapeutic, P32 directly to solid tumors and is presently in Phase II clinical trials for the treatment of pancreatic cancer. For more information, please visit www.psivida.com

SOURCE: Alimera Sciences pSivida Limited

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