08.10.2007 12:00:00
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Enrollment Complete in Pivotal Phase III Trial of Medidur(TM) FA for Diabetic Macular Edema
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
Various statements made in this release are forward-looking and involve
a number of risks and uncertainties. All statements that address
activities, events or developments that we intend, expect or believe may
occur in the future are forward-looking statements. The following are
some of the factors that could cause actual results to differ materially
from the forward-looking statements: the risks that we will not be able
to raise additional capital; that we will continue to incur losses and
may never become profitable; that we will be required to pay penalties
pursuant to registration agreements with securities holders and not have
sufficient funds to do so; that we will be unable to develop new
products; that we will be unable to protect our own intellectual
property or will infringe on others’
intellectual property; that we will not receive regulatory approvals
necessary to commercialize products; that we will be unable to secure
partners necessary to develop and market products; that our current
licensees will terminate their agreements with us; that our competitors’
products will receive regulatory approval before, reach the market
before, or otherwise receive better market acceptance than, our product
candidates; that our international business operations will result in
increased costs or delays; that manufacturing problems will delay
product development and commercialization; that third-party
reimbursement and health care providers will not cover the costs of our
products; that we will fail to retain some or all of our key personnel;
we will be subject to product liability suits and not have sufficient
insurance to cover damages; that we will fail to effectively manage
changes in our business; that we will fail to comply with environmental
laws and regulations; that we will fail to achieve and maintain
effective internal control over financial reporting; that amortization
or impairment of other intangibles will adversely affect our operating
results; that our being headquartered outside of the United States will
make it difficult to effect legal services against us or our management,
lead to adverse shareholder tax consequences, or otherwise limit
shareholder rights; that we will be delisted from the ASX or NASDAQ;
that our expectation to not pay cash dividends will decrease our stock
price; that exercise of outstanding warrants and stock options will
dilute ownership and reduce stock price; that future stock issuances
could dilute ownership, restrict operations, encumber assets, or
otherwise cause a decline in stock price; and the risk that Pfizer will
influence our business in non-beneficial ways; and other factors that
may be described in our filings with the Securities and Exchange
Commission. Given these uncertainties, readers are cautioned not to
place undue reliance on such forward-looking statements. We do not
undertake to publicly update or revise our forward-looking statements
even if experience or future changes make it clear that any projected
results expressed or implied in such statements will not be realized.
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