pSivida Submits Marketing Authorization Application (MAA) for Approval of Durasert™ Three-year Treatment for Posterior Segm...
June 22 2017 - 7:00AM
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development
of sustained release drug products and technologies, has submitted
a Marketing Authorization Application (MAA) to the European
Medicines Agency (EMA), seeking approval to market the Company’s
Durasert three-year treatment for posterior segment uveitis in the
European Union (EU).
”Our MAA submission is another significant
milestone delivered on time by the pSivida team,” commented Nancy
Lurker, President and Chief Executive Officer. “Durasert three-year
uveitis treatment, our lead product candidate, has now proven to be
highly effective in reducing the recurrence of uveitis in two Phase
3 studies. Both studies illustrate the benefits Durasert
brings to those patients suffering from this disease, which is a
leading cause of blindness. As we await the review from the
EU regulators, we continue to have advanced discussions with
potential partners and are focused on entering into an
out-licensing agreement for Durasert in the EU sometime this
summer.”
In each of pSivida’s two Phase 3 trials for its
Durasert three-year uveitis treatment, the primary efficacy
endpoint was successfully achieved at six months with a p value
<0.001. In addition, the safety profile of patients treated with
Durasert three-year uveitis treatment was comparable to the safety
profile of existing steroid uveitis treatments, which are
considered standard of care for this disease.
Posterior 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. and EU, posterior uveitis affects ~200,000
people, annually. 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 three EU countries. Retisert®, an implant
for posterior uveitis, is licensed to and sold by Bausch &
Lomb. pSivida's lead product candidate, Durasert™ micro-insert for
posterior segment uveitis being independently developed, is
currently in pivotal Phase 3 clinical trials. 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; further impairment
of our intangible assets; successful commercialization of, and
receipt of revenues from, ILUVIEN® for diabetic macular edema
(“ILUVIEN”), which depends on Alimera’s ability to continue as a
going concern 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
applications in the U.S. and EU; our ability to file and the timing
of filing and acceptance of the Durasert three-year uveitis
marketing approval applications in the U.S. and EU; our ability to
use data in a U.S. NDA from clinical trials outside the U.S.;
maintenance of European orphan designation for Durasert three-year
uveitis; our ability to successfully commercialize Durasert
three-year uveitis, if approved; potential off-label sales of
ILUVIEN for uveitis; consequences of fluocinolone acetonide side
effects; potential declines in Retisert® royalties; our ability to
develop Tethadur to successfully deliver large biologic molecules
and develop products using it; 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; termination or breach of current license agreements;
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:
EVC Group
Michael Polyviou/Doug Sherk – Investors
mpolyviou@evcgroup.com; dsherk@evcgroup.com
212.850.6020; 646-445-4800
Thomas Gibson – Media
tom@tomgibsoncommunications.com
201-476-0322
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