pSivida Announces FDA Acceptance For Filing of New Drug Application (NDA) for Durasert™ Three-Year Treatment for Posterior ...
March 19 2018 - 12:35PM
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development
of sustained release drug products and technologies, today
announced that its New Drug Application (NDA) for Durasert
three-year treatment for posterior segment uveitis has been
accepted by the U.S. Food and Drug Administration (FDA) for filing.
The acceptance of the NDA reflects the FDA’s determination that the
application is sufficiently complete to permit a substantive
review. The application will be subject to a standard review and
will have a Prescription Drug User Fee Act (PDUFA) date of November
5, 2018. The PDUFA date is the goal date for the FDA to complete
its review of the NDA.
The NDA includes data from two Phase 3 studies
that each successfully achieved the primary efficacy endpoint at
six months with a p value < 0.001. In addition, the safety
profile in patients treated with Durasert three-year for posterior
segment uveitis was consistent with the safety profile of steroid
treatments that are currently considered standard of care for this
disease.
"The FDA’s acceptance for review of our Durasert NDA submission
is a major milestone for pSivida and we look forward to continuing
to work with the FDA as they review our application," commented
Nancy Lurker, President and CEO. "Given the high unmet
medical need, we believe that Durasert, if approved, has the
potential to become an important new treatment option for the
thousands of patients suffering from posterior segment uveitis, the
third leading cause of blindness.”
About Posterior Segment
UveitisPosterior segment uveitis is a chronic,
non-infectious inflammatory disease affecting the posterior segment
of the eye, often involving the retina, which is believed to be a
leading cause of blindness in the developed and developing
countries. It affects people of all ages, producing swelling and
destroying eye tissues, which can lead to severe vision loss and
blindness. In the U.S., posterior segment uveitis affects between
80,000 - 100,000 people. Today, patients with posterior uveitis are
typically treated with systemic steroids, but over time frequently
develop serious side effects that can limit effective dosing.
Patients then often progress to steroid-sparing therapy with
systemic immune suppressants or biologics, which themselves can
have severe side effects including an increased risk of cancer.
About pSivida Corp.pSivida
Corp. (www.psivida.com), headquartered in Watertown, MA, is a
leader in the development of sustained release drug products for
treating eye diseases. pSivida has developed three of only four
FDA-approved sustained-release treatments for back-of-the-eye
diseases. The most recent, ILUVIEN®, a micro-insert for diabetic
macular edema, licensed to Alimera Sciences, is currently sold
directly in the U.S. and several EU countries. Retisert ®, an
implant for posterior uveitis, is licensed to and sold by Bausch
& Lomb. In January 2018, pSivida submitted a New Drug
Application (NDA) to the U.S. FDA for its lead product candidate,
Durasert™ micro-insert for posterior segment uveitis. The NDA has
been accepted for filing and is currently under standard review
with a Prescription Drug User Fee Act (PDUFA) date of November 5,
2018. Two pivotal Phase 3 studies with Durasert achieved their
primary efficacy endpoint of prevention of recurrence of uveitis at
six months of follow-up with statistical significance. pSivida's
pre-clinical development program is focused on using its core
platform technology Durasert to deliver drugs to treat wet
age-related macular degeneration, glaucoma, osteoarthritis and
other diseases. To learn more about pSivida, please
visit www.psivida.com and connect on Twitter, LinkedIn,
Facebook and Google+.
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.
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
include uncertainties with respect to: our ability to achieve
profitable operations and access to needed capital; fluctuations in
our operating results; successful commercialization of, and receipt
of revenues from, ILUVIEN® for diabetic macular edema ("DME"),
which depends on Alimera's ability to continue as a going concern;
Alimera's ability to obtain marketing approvals and the effect of
pricing and reimbursement decisions on sales of ILUVIEN; the number
of clinical trials and data required for the Durasert three-year
uveitis marketing approval application in the U.S.; our ability to
use data in a U.S. NDA from clinical trials outside the U.S.; our
ability to successfully commercialize Durasert three-year uveitis,
if approved, in the U.S.; potential off-label sales of ILUVIEN for
uveitis; consequences of fluocinolone acetonide side effects; the
development of our next-generation Durasert shorter-duration
treatment for posterior segment uveitis; potential declines in
Retisert® royalties; efficacy and our future development of an
implant to treat severe osteoarthritis; our ability to successfully
develop product candidates, initiate and complete clinical trials
and receive regulatory approvals; our ability to market and sell
products; the success of current and future license agreements,
including our agreement with Alimera; termination or breach of
current license agreements, including our agreement with Alimera;
our dependence on contract research organizations, vendors and
investigators; effects of competition and other developments
affecting sales of products; market acceptance of products; effects
of guidelines, recommendations and studies; protection of
intellectual property and avoiding intellectual property
infringement; retention of key personnel; product liability;
industry consolidation; compliance with environmental laws;
manufacturing risks; risks and costs of international business
operations; effects of the potential U.K. exit from the EU;
legislative or regulatory changes; volatility of stock price;
possible dilution; absence of dividends; and other factors
described in our filings with the Securities and Exchange
Commission. You should read and interpret any forward-looking
statements in light of these risks. Should known or unknown risks
materialize, or should underlying assumptions prove inaccurate,
actual results could differ materially from past results and those
anticipated, estimated or projected in the forward-looking
statements. You should bear this in mind as you consider any
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.
Contact:
Barbara Ryan –
InvestorBarbara@barbararyanadvisors.co203-274-2825
Thomas Gibson –
Mediatom@tomgibsoncommunications.com201-476-0322
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