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ENROLLMENT COMPLETE IN PIVOTAL PHASE III TRIAL OF
MEDIDUR™ FA FOR DIABETIC MACULAR EDEMA
ATLANTA, 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