Alimera Sciences Inc., a privately held
ophthalmic pharmaceutical company, and pSivida Limited (Nasdaq: PSDV; ASX:
PSD; Xetra: PSI), announced that enrollment is complete for the
FAME(TM) (Fluocinolone Acetonide in Diabetic Macular Edema) Study of
Medidur(TM) 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., a 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 3 clinical trial of fluocinolone acetonide in
the Medidur(TM) drug delivery system for the treatment of diabetic macular
edema. For more information, please visit alimerasciences
About pSivida Limited
pSivida is a global drug delivery company committed to the biomedical
sector. Retisert(R) is FDA approved for the treatment of uveitis.
Vitrasert(R) is FDA approved for the treatment of AIDS-related CMV
Retinitis. Bausch & Lomb own the trademarks Vitrasert(R) and Retisert(R).
pSivida has licensed the technologies underlying both of these products to
Bausch & Lomb. The technology underlying Medidur(TM) 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(TM)
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(TM),
which has applications in drug delivery, wound healing, orthopedics, and
tissue engineering. The most advanced BioSilicon(TM) product, BrachySil(TM)
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 psivida
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.
Alimera Sciences Inc.
alimerasciences