pSivida Reports ILUVIEN® Available in UK

  pSivida Reports ILUVIEN® Available in UK

       Simple Patient Access Scheme Submitted to NICE for Rapid Review

Business Wire

WATERTOWN, Mass. -- April 29, 2013

pSivida Corp. (NASDAQ:PSDV; ASX:PVA), a specialty pharmaceutical company that
is a leader in the development of sustained release ophthalmic drug
treatments, today announced ILUVIEN® , the first sustained release
pharmaceutical product for the treatment of chronic diabetic macular edema
(DME), is now available in the UK for treatment of private pay and privately
insured patients, as reported by its licensee, Alimera Sciences.

Alimera also reported that it has recently submitted a simple Patient Access
Scheme (PAS) to the United Kingdom’s National Institute for Health and Care
Excellence (NICE) for consideration of the guidance under rapid review. The
NICE Appraisal Committee will assess the likely impact of the ILUVIEN PAS and
determine whether an update to NICE’s previously issued final guidance is
warranted, according to Alimera. If the PAS is accepted by NICE, Alimera
further reported that ILUVIEN would be funded for chronic DME patients in
England and Wales through the National Health Service (NHS). Alimera reported
that the NICE Appraisal Committee is scheduled to meet on May 15, 2013 to
discuss the ILUVIEN PAS submission with an expected 30-day review period to
follow.

“We are pleased that ILUVIEN is now available in the UK,” said Dr. Paul
Ashton, pSivida president and CEO. “This marks the first availability of a
sustained release therapy for patients who suffer from DME and who have not
responded to conventional therapies. We believe it provides a welcome
additional treatment option for retinal specialists in the UK treating private
pay and privately insured patients. We are hopeful that the Patient Access
Scheme will be approved and make ILUVIEN available to a larger group of
chronic DME patients who are considered insufficiently responsive to available
therapies.”

ILUVIEN (190 micrograms intravitreal implant in applicator) is a sustained
release intravitreal implant used to treat vision impairment associated with
chronic DME considered insufficiently responsive to available therapies. Each
ILUVIEN implant provides a therapeutic effect of up to 36 months by delivering
sustained sub-microgram levels of fluocinolone acetonide (FAc). ILUVIEN is
injected in the back of the patient’s eye to a position that takes advantage
of the eye’s natural fluid dynamics. The applicator employs a 25-gauge needle,
which allows for a self-sealing wound. To date, ILUVIEN has been granted
national licenses for commercialization by six countries, Austria, the United
Kingdom, Portugal, France, Spain and Germany. The national phase in Italy is
currently ongoing. ILUVIEN has not been approved by the United States Food and
Drug Administration.

pSivida has developed three of the four sustained release devices for retinal
diseases that have been approved in either the US or Europe, the most recent
being ILUVIEN. Independently, pSivida is developing an injectable, sustained
release product to treat uveitis affecting the back of the eye (posterior
uveitis) and an injectable, bioerodible product to treat glaucoma and ocular
hypertension in collaboration with Pfizer.

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 Diabetic Macula Edema (DME), licensed to
Alimera Sciences, Inc., has received marketing authorization in Austria,
France, Germany, Portugal, the U.K. and Spain and is awaiting authorization in
Italy. ILUVIEN® for DME has not been approved in the US. 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
FDA-approved product Retisert® is an implant that provides long-term,
sustained drug delivery to treat posterior uveitis, a chronic disease 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: the FDA’s acceptance of Alimera’s
resubmission of its NDA for ILUVIEN® for DME and 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 timing of the commercial
launch in Germany and the UK, any effect of the PAS on the NICE final
guidance, 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; 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.

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

Contact:

In US:
Martin E. Janis & Company, Inc.
Beverly Jedynak, 312-943-1123 or 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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