BUSINESS WIRE
WATERTOWN, Mass.--(BUSINESS WIRE)--pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of
sustained release back of the eye drug delivery systems for
difficult-to-treat conditions, today announced that its licensee,
Alimera Sciences (NASDAQ:ALIM) has submitted a New Drug Application
(NDA) to the U.S. Food and Drug Administration for Iluvien® for Diabetic
Macular Edema. Iluvien, developed by pSivida and licensed to Alimera
Sciences in 2005, is a sustained release drug delivery system releasing
the steroid flucocinolone acetonide for the treatment of diabetic
macular edema (DME). In the submission, Alimera requested priority
review, which, if granted, could result in an action letter from the FDA
in the fourth quarter of this year.
Dr. Paul Ashton, President and CEO of pSivida, said, “There are
currently no drugs approved to treat DME, one of the leading causes of
vision loss. Iluvien’s clinical trials have demonstrated that Iluvien
can significantly improve vision in DME patients.” Dr. Ashton continued,
“This is our third product for back-of-the-eye diseases to be submitted
to the FDA for approval. The first two were approved, are currently on
the market and are two of the only three sustained release drug delivery
systems currently approved by the FDA to treat back-of-the-eye
conditions."
Two pivotal phase three clinical trials (collectively known as the FAME
Study) for Iluvien involving 956 patients in sites across the United
States, Canada, Europe and India are being completed to assess the
efficacy and safety of Iluvien for the treatment of DME. The primary
efficacy endpoint for the FAME Study is the difference in the percentage
of patients whose best corrected visual acuity (BCVA) improved by 15 or
more letters from baseline on the ETDRS eye chart at month 24 between
the treatment and control groups. The study will conclude later this
year with the final patient visits at the three-year data point. The
24-month clinical read out from the study was announced in December 2009.
The NDA submission includes the 24-month low dose data from the FAME
Study. Alimera has indicated that it plans to follow this NDA submission
with registration filings in certain European countries and Canada in
the near future. pSivida has joint ownership and reference rights to
this NDA.
pSivida continues to work to develop new products for the sustained
release of drugs and proteins based on its existing and new
technologies. Additionally, Pfizer and pSivida are collaborating to
develop ophthalmic products based on pSivida technology. While the
Company remains primarily focused in ophthalmology, pSivida is exploring
other therapeutic areas.
About pSivida Corp.
pSivida Corp is a world leader in the development of tiny, sustained
release, drug delivery products and technologies that are administered
by implantation, insertion or injection. The Company uses these systems
to develop treatments for serious, unmet, medical needs. pSivida’s
intellectual property portfolio consists of 59 patent families, more
than 100 granted patents, including patents accepted for issuance, and
more than 150 patent applications. pSivida conducts its operations from
Boston in the United States and Malvern in the United Kingdom.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995: Various statements made in this release are
forward-looking, and are inherently subject to risks, uncertainties and
potentially inaccurate assumptions. 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 anticipated results or other expectations expressed,
anticipated or implied in our forward-looking statements: maintaining
collaboration agreements with Alimera and Pfizer; modifications of
existing terms of collaboration agreements with Alimera and Pfizer;
achievement of milestones and other contingent contractual events;
ability to prove safety and efficacy of, and achieve regulatory
approvals for, and successfully commercialize Iluvien, BrachySil and
other products;; ability to raise capital; ability to achieve
profitability; ability to derive revenues from Retisert; ability to
develop new products; impairment of intangibles; fluctuations in the
fair values of certain outstanding warrants; fluctuations in operating
results; termination of license agreements; ability to obtain partners
to develop and market products; competition; extent of third-party
reimbursement for products; product liability; ability to protect
intellectual property or infringement of others’ intellectual property;
retention of key personnel; consolidation in the pharmaceutical and
biotechnology industries; compliance with laws; maintaining effective
internal control over financial reporting; manufacturing risks; risks
and costs of international business operations; volatility of stock
price; possible dilution through exercise of outstanding warrants and
stock options or future stock issuances; possible influence by Pfizer;
ability to pay any registration penalties; and other factors 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. Our forward-looking statements speak only as
of the dates on which they are made. We do not undertake any obligation
to publicly update or revise our forward-looking statements even if
experience or future changes makes it clear that any projected results
expressed or implied in such statements will not be realized.