pSivida Corp. Receives FDA Clearance for Pivotal Trials for Injectable Sustained-Release Micro-Insert to Treat Uveitis

  pSivida Corp. Receives FDA Clearance for Pivotal Trials for Injectable
  Sustained-Release Micro-Insert to Treat Uveitis

Business Wire

WATERTOWN, Mass. -- July 19, 2012

pSivida Corp. (NASDAQ: PSDV)(ASX: PVA), a leader in developing sustained
release, drug delivery products for treatment of back-of-the-eye diseases,
today announced that the U.S. Food and Drug Administration (FDA) has cleared
its Investigational New Drug (IND) application to treat posterior uveitis with
pSivida’s injectable sustained-release micro-insert. pSivida is now permitted
to move directly to two Phase III trials to treat patients with posterior
uveitis. These trials, which pSivida expects would enroll a total of 300
patients, would be in addition to the investigator-sponsored trial studying
the same device for posterior uveitis announced last month.

“We are very pleased to be cleared to commence phase III clinical trials for
the treatment of this blinding disease without the necessity of Phase I or
Phase II trials,” said Dr. Paul Ashton, President and CEO of pSivida Corp.
“Importantly, the FDA has agreed that the primary end point in these trials
will be recurrence of uveitis within 12 months and that we can reference much
of the data, including the clinical safety data, from the clinical trials for
ILUVIEN® for Diabetic Macular Edema (DME) conducted by our collaborative
partner Alimera Sciences, Inc. (Alimera). We appreciate the input provided by
the FDA about the design of these trials and believe these design features
will be advantageous in terms of cost and time.

“Because the micro-insert delivers the same drug as our approved Retisert®
product for posterior uveitis, we expect to these trials will show efficacy.
Further, as the same micro-insert was used in the ILUVIEN trials, we expect to
observe a comparable side-effect profile in uveitis patients as was seen in
DME patients. As a result, we are optimistic that our micro-insert will be
efficacious for posterior uveitis with a favorable risk/benefit profile and
fewer side effects than Retisert.”

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 is
responsible for approximately 30,000 cases of blindness, making it the third
largest cause of blindness.

pSivida’s injectable micro-insert to treat posterior uveitis is a tiny tube
about the size of an eyelash. It releases the off-patent steroid fluocinolone
acetonide at a consistent rate over a period of approximately 36 months. The
micro-insert is injected into the back of the eye during an office visit
through the use of a fine gauge needle. The same micro-insert has recently
received marketing authorization for chronic DME considered insufficiently
responsive to available therapies in the UK, Austria, France and Portugal
following a positive review under the Decentralized Procedure. Marketing
authorization in the remaining countries is anticipated in the coming months.
Alimera has reported that it expects the insert, to be marketed under the name
ILUVIEN, to be the first sustained-release pharmaceutical in the EU to treat
DME.

About pSivida Corp.

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™. ILUVIEN® for the treatment of Diabetic Macular
Edema (DME), which is licensed to Alimera Sciences, Inc., is pSivida’s most
advanced product candidate. It has received marketing authorization for
chronic DME considered insufficiently responsive to available therapies in the
UK, France, Austria and Portugal following a positive review by Austria,
France, German, Italy, Portugal, Spain and the UK under the Decentralized
Procedure. Marketing authorization in the remaining countries is anticipated
in the coming months. An investigator-sponsored clinical trial is ongoing for
an injectable, bioerodible insert to treat glaucoma and ocular hypertension.
pSivida’s two FDA-approved products, Retisert® and Vitrasert®, are implants
that provide long-term, sustained drug delivery to treat two other chronic
diseases of the retina.

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: necessity to raise additional capital to finance Phase III uveitis
trials as well as other working capital needs; ability to obtain additional
capital; ability to initiate and complete clinical trials and obtain
regulatory approval of product candidates; adverse side effects; Alimera’s
ability to successfully obtain regulatory approval of and commercialize
ILUVIEN for DME in the EU; actions with respect to regulatory approval of
ILUVIEN for DME in the U.S.; ability to attain profitability; exercise by
Pfizer of the Latanoprost Product option; further impairment of intangible
assets; fluctuations in operating results; decline in royalty revenues;
ability to find partners to develop and market products; termination of
license agreements; competition; market acceptance of products and product
candidates; reduction in use of products as a result of future guidelines,
recommendations or studies; ability to protect intellectual property and avoid
infringement of others’ intellectual property; 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; ability to pay any
registration penalties; absence of dividends; 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.

Contact:

US Public Relations
Martin E. Janis & Company, Inc
Beverly Jedynak, President
+1 (312) 943 1123
bjedynak@janispr.com
pSivida Corp.
Brian Leedman, Vice President, Investor Relations
+61 (0) 41 228 1780
brianl@psivida.com
 
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