pSivida Announces That U.K.’s NICE Recommends ILUVIEN® for Chronic Diabetic Macular Edema in Pseudophakic Eyes; NHS

  pSivida Announces That U.K.’s NICE Recommends ILUVIEN® for Chronic Diabetic
  Macular Edema in Pseudophakic Eyes; NHS Reimbursement Expected to Follow

Business Wire

WATERTOWN, Mass. -- September 30, 2013

pSivida Corp. (NASDAQ: PSDV)(ASX: PVA), a specialty pharmaceutical company
that is a leader in developing sustained release drugs for treatment of
back-of-the-eye diseases, today announced that the United Kingdom’s National
Institute for Health and Care Excellence (NICE) issued final draft guidance
recommending ILUVIEN as an option for the treatment of chronic diabetic
macular edema (DME) that is insufficiently responsive to available therapies
in pseudophakic eyes (those that have already undergone cataract surgery).
This recommendation reverses the final draft guidance previously issued by
NICE with respect to this subgroup of chronic DME patients.

NICE’s final guidance recommending ILUVIEN to the National Health Service
(NHS) is expected to be published in November 2013, which would result in NHS
reimbursement in England and Wales under the patient access scheme submitted
by Alimera Sciences, pSivida’s licensee.

“We are very pleased with this position by NICE and the expectation that
ILUVIEN will be available to treat this significant subgroup of chronic DME
patients,” said Dr. Paul Ashton, President and CEO of pSivida. “We are
encouraged that Alimera plans to continue to work with NICE in an effort to
broaden access to ILUVIEN to include all chronic DME patients who could
benefit from the treatment.”

ILUVIEN, a sustained release intravitreal micro-insert, has received marketing
authorization in the U.K., Austria, Portugal, Germany, France and Spain, and
is pending in Italy. ILUVIEN is currently commercially available in the U.K.
and Germany.

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™, including Tethadur™. The injectable, sustained
release micro-insert ILUVIEN® for the treatment of chronic Diabetic Macula
Edema (DME) considered insufficiently responsive to available therapies,
licensed to Alimera Sciences, Inc., is marketed in the U.K. and Germany and
has also received marketing authorization in Austria, France, Portugal, and
Spain and is awaiting authorization in Italy. Alimera resubmitted the New Drug
Application for ILUVIEN for DME to the U.S. Food and Drug Administration and
received a PDUFA date of October 17, 2013. pSivida has instituted the first of
two planned pivotal Phase III clinical trials for Medidur™ 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, a product candidate on which Pfizer Inc. has an option.
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: issuance of final NICE guidance and
any action by NICE to broaden patients for whom ILUVIEN is recommended;
Alimera’s ability to finance, achieve additional marketing approvals,
successfully complete pricing and reimbursement discussions for, commercialize
and achieve market acceptance of, and generate revenues to pSivida from,
ILUVIEN for DME in the EU; 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.; the ability to finance, complete and achieve a successful outcome
for Phase III trials for, and file and achieve marketing approvals for,
Medidur for posterior uveitis, including efficacy, side effects and
risk/benefit profile, as well as uncertainty as to the ultimate results of the
investigator-sponsored trial for Medidur for posterior uveitis; initiation,
financing and success of Latanoprost Product Phase II trials and exercise by
Pfizer of its option; ability to utilize Tethadur and BioSilicon to develop
product candidates and products and potential related collaborations;
initiation and completion of clinical trials and obtaining regulatory approval
of product candidates; continued sales of Retisert; adverse side effects;
ability to attain profitability; ability to obtain additional capital; further
impairment of intangible assets; fluctuations in operating results; decline in
royalty income; 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; 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.

Follow pSivida on social media:

Twitter: https://twitter.com/pSividaCorp

Facebook: https://www.facebook.com/pages/PSivida-Corp/544893792199562

LinkedIn: http://www.linkedin.com/company/psivida

Google+:
https://plus.google.com/u/0/b/113754643626984244726/113754643626984244726/posts

The President's Blog: http://www.thechairmansblog.com/paul-ashton

For more information on pSivida, visit www.psivida.com.

Contact:

In US:
Martin E. Janis & Company, Inc.
Beverly Jedynak
President
+1 312 943 1123
M: +1 773 350 5793
bjedynak@janispr.com
or
In Australia:
pSivida Corp.
Brian Leedman
Vice President, Investor Relations
+61 (0) 41 228 1780
brianl@psivida.com
 
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