WATERTOWN, Mass.--(BUSINESS WIRE)--
pSivida Corp. (NASDAQ:PSDV), a specialty pharmaceutical company that is
a leader in developing sustained release drugs for treatment of
back-of-the-eye diseases, today announced that it has initiated the
first of two planned pivotal Phase III trials of its micro-insert for
the treatment of chronic, non-infectious uveitis affecting the posterior
segment of the eye, a major cause of vision loss in the U.S.
"We are extremely pleased that our first three U.S. clinical sites have
begun recruiting patients for this trial," said Paul Ashton, Ph.D.,
President and CEO of pSivida. "We are very optimistic that our
micro-insert will be efficacious for the treatment of posterior uveitis
with a more favorable risk/benefit profile, fewer side effects and
greater ease of administration than Retisert®, our current FDA-approved
product for the treatment of the same disease."
The micro-insert, a tiny tube about the size of an eyelash that releases
the steroid fluocinolone acetonide on a sustained basis for up to 36
months, is the same micro-insert licensed by pSivida to Alimera
Sciences, Inc. Alimera has received marketing approval for the
micro-insert in six EU countries for the treatment of vision impairment
associated with chronic diabetic macular edema (DME) considered
insufficiently responsive to available therapies and has commenced the
direct commercialization of the micro-insert in Germany and the United
Kingdom under the name ILUVIEN®. The FDA has set a new Prescription Drug
User Fee Act (PDUFA) goal date of October 17, 2013 for ILUVIEN. pSivida
did not license the micro-insert to Alimera for the treatment of uveitis
and is developing this product without a partner.
This is the first of two pivotal trials required by the FDA for approval
of the micro-insert for the treatment of posterior uveitis. These trials
are planned to involve approximately 15 U.S. clinical sites and
additional sites world-wide. Both trials will have a primary end-point
of recurrence of posterior uveitis at 12 months and are planned to
involve approximately 300 patients in total. If the results of the
trials are positive, the data will be used by pSivida to submit a New
Drug Application to the FDA. The FDA has confirmed that pSivida will be
able to reference much of the data, including the clinical safety data,
from Alimera's Phase III clinical trials of ILUVIEN for chronic DME.
Posterior uveitis is an inflammatory disease of one of the layers of the
eye. In the U.S., posterior uveitis affects approximately 175,000 people
and can be difficult to treat effectively, resulting in an estimated
30,000 cases of blindness in the U.S.
"In our uveitis trials, we expect to maintain similar efficacy to that
seen in the Retisert Phase III trials but with a similar side-effect
profile to that seen in DME patients in the Phase III studies for
ILUVIEN," said Dr. Ashton. "The Retisert implant is FDA approved for
posterior uveitis and the micro-insert delivers the same drug as
Retisert, so we expect the micro-insert to be efficacious. Based on the
Phase III studies for ILUVIEN, we also expect the micro-insert to have a
lower incidence of serious increased in intraocular pressure (IOP) than
Retisert. The ILUVIEN studies showed an incidence of serious elevated
IOP that was three times lower than that seen in the Retisert Phase III
trials, and the incidence of patients requiring surgery for increased
IOP in the ILUVIEN studies was seven times lower. The micro-insert
releases drug at a slower rate and is also easier to administer than
Retisert, because the micro-insert is injected in an office visit while
Retisert must be implanted in a surgical procedure."
About pSivida
pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained
release, drug delivery products designed to deliver drugs at a
controlled and steady rate for months or years. pSivida is currently
focused on treatment of chronic diseases of the back of the eye
utilizing its core technology systems, Durasert™ and BioSilicon™. The
injectable, sustained release micro-insert ILUVIEN® for the treatment of
chronic DME considered insufficiently responsive to available therapies,
licensed to Alimera Sciences, Inc., has received marketing authorization
in Austria, France, Germany, Portugal, Spain and the U.K. and is
awaiting authorization in Italy. Alimera has resubmitted the New Drug
Application for ILUVIEN for DME to the U.S. Food and Drug
Administration. pSivida plans to institute pivotal Phase III clinical
trials for the treatment of posterior uveitis, a chronic back-of-the-eye
disease, with the same micro-insert as ILUVIEN for DME. An
investigator-sponsored clinical trial is ongoing for an injectable,
bioerodible micro-insert to treat glaucoma and ocular hypertension.
pSivida's FDA-approved Retisert® licensed to Bausch & Lomb Incorporated
provides long-term, sustained drug delivery to treat posterior uveitis.
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: uncertainties
with respect to: the success of Phase III posterior uveitis trials
including efficacy, side effects and risk/benefit profile of the
posterior uveitis micro-insert and pSivida's ability to finance and
complete the trials and receive marketing approvals; Alimera's ability
to achieve a positive NICE recommendation for all ILUVIEN patients;
Alimera's ability to obtain regulatory approval for, and if approved, to
finance, successfully commercialize and achieve market acceptance of,
and generate revenues to pSivida from, ILUVIEN for DME in the U.S.;
Alimera's ability to finance, achieve additional marketing approvals,
successfully commercialize and achieve market acceptance of, and
generate revenues to pSivida from, ILUVIEN for DME in the EU; outcome of
reimbursement for ILUVIEN in the U.K.; initiation, financing and success
of Latanoprost Product Phase II trials and exercise by Pfizer of its
option; development of products using Tethadur and BioSilicon;
initiation and completion of clinical trials and obtaining regulatory
approval of product candidates; adverse side effects; ability to attain
profitability; ability to obtain additional capital; further impairment
of intangible assets; fluctuations in operating results; decline in
royalty revenues; ability to, and to find partners to, develop and
market products; termination of license agreements; competition and
other developments affecting sales of products; market acceptance;
protection of intellectual property and avoiding intellectual property
infringement; retention of key personnel; product liability;
consolidation in the pharmaceutical and biotechnology industries;
compliance with environmental laws; manufacturing risks; risks and costs
of international business operations; credit and financial market
conditions; legislative or regulatory changes; volatility of stock
price; possible dilution; possible influence by Pfizer; absence of
dividends; and other factors described in our filings with the SEC.
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.
IN US:
Martin E. Janis & Company, Inc.
Beverly Jedynak,
312-943-1123; 773-350-5793 (cell)
President
bjedynak@janispr.com
or
IN
AUSTRALIA:
pSivida Corp.
Brian Leedman, +61 (0) 41 228 1780
Vice
President, Investor Relations
brianl@psivida.com
Source: pSivida Corp.
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