pSivida Corp. Announces Initiation of Phase III Clinical Trial in Posterior Uveitis

  pSivida Corp. Announces Initiation of Phase III Clinical Trial in Posterior
  Uveitis

Business Wire

WATERTOWN, Mass. -- July 1, 2013

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.

Contact:

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
 
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