pSivida Corp. Announces Spain Grants ILUVIEN® Marketing Approval for Chronic Diabetic Macular Edema

  pSivida Corp. Announces Spain Grants ILUVIEN® Marketing Approval for Chronic
  Diabetic Macular Edema

Business Wire

WATERTOWN, Mass. -- January 17, 2013

pSivida Corp. (NASDAQ:PSDV - News), a leader in developing sustained release,
drug delivery products for treatment of back-of-the-eye diseases, announced
today that the Spanish Agency of Drugs and Medical Devices (Agencia Espanola
de Medicamentos y Productos Sanitarios) granted marketing authorization to
ILUVIEN^® for the treatment of vision impairment associated with chronic
diabetic macular edema (DME) considered insufficiently responsive to available
therapies.

The Spanish authorization is the sixth national approval for ILUVIEN in the
EU, preceded by Austria, theUnited Kingdom, Portugal, FranceandGermany.
pSivida’s licensee Alimera Sciences, Inc. reported that it continues to work
closely with the Italian regulatory authorities to secure marketing
authorization in Italy. These marketing authorizations follow the completion
of the Decentralized Regulatory Procedure (DCP) in the European Union (EU), in
which the Medicines and Healthcare products Regulatory Agency (MHRA) in the
United Kingdom, serving as the Reference Member State (RMS), delivered a
positive outcome for ILUVIEN along with six Concerned Member States (CMS).

Dr. Paul Ashton, President and CEO, said, “We are pleased that ILUVIEN has now
been granted marketing authorizations in six of the seven EU countries in
which approval has been sought and look forward to its commercial launch in
the EU.”

Alimera reported that it continues to expect the initial commercial launch of
ILUVIEN in Germany during the first quarter of 2013 with its European
management team now on board.

The International Diabetes Federation estimates that more than three million
people are currently living with diabetes in Spain, approximately 160,000 of
whom Alimera estimates suffer from vision loss associated with 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™. The injectable, sustained release micro-insert
ILUVIEN® for the treatment of chronic DME, 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. ILUVIEN for DME has
not been approved in the U.S. pSivida plans to institute pivotal Phase III
clinical trials for the treatment of posterior uveitis 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 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: uncertainties with respect to: 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., Alimera's
resubmission of its NDA for ILUVIEN for DME and its 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.; financing and success of Phase III
posterior uveitis trials including efficacy, side effects and risk/benefit
profile of the posterior uveitis micro-insert; 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:

US Public Relations
Martin E. Janis & Company, Inc
Beverly Jedynak, +1 312-943-1123
President
bjedynak@janispr.com
or
pSivida Corp.
Brian Leedman, +61 (0) 41 228 1780
Vice President, Investor Relations
brianl@psivida.com
 
Press spacebar to pause and continue. Press esc to stop.