pSivida Corp. Announces UK’s NICE Says Yes to ILUVIEN® in Some Patients with Diabetic Macular Edema in New Draft Guidance

  pSivida Corp. Announces UK’s NICE Says Yes to ILUVIEN® in Some Patients with
  Diabetic Macular Edema in New Draft Guidance

Business Wire

WATERTOWN, Mass. -- June 14, 2013

pSivida Corp. (NASDAQ:PSDV - News), a leader in developing sustained release,
drug delivery products for treatment of back-of-the-eye diseases, today
announced that the United Kingdom’s National Institute for Health and Care
Excellence (NICE) issued draft guidance recommending ILUVIEN® for the
treatment of pseudophakic patients (those who have undergone prior cataract
surgery) with chronic diabetic macular edema (DME) considered insufficiently
responsive to available therapies. Following a rapid review by NICE, this
recommendation proposes a change to the published guidance issued by NICE in
January 2013 and takes into consideration a patient access scheme (PAS)
submitted by Alimera.

“We are very pleased. If this recommendation becomes final, ILUVIEN will be
available in the U.K. to pseudophakic as well as private pay and privately
insured patients,” said Dr. Paul Ashton, Chief Executive Officer of pSivida.
“The pseudophakic DME population represents a large subgroup as patients with
DME have a far higher incidence of cataract than the overall population. In
the Phase III FAME™ trials of ILUVIEN, over 50% of control patients were
pseudophakic at the end of the trial.”

The NICE Appraisal Committee making the recommendation confirmed the
conclusions that ILUVIEN is clinically effective in the treatment of vision
impairment associated with chronic DME considered insufficiently responsive to
available therapies as well as in the subgroup of pseudophakic chronic DME
patients. Based on the PAS, the Committee concluded that the
cost-effectiveness threshold had been met for the subgroup of chronic DME
patients who are pseudophakic. NICE will issue final guidance after a comment

Professor Carole Longson, Health Technology Evaluation Center Director at NICE
said, “Around 336,000 people with diabetes in the UK have diabetic macular
edema... NICE is pleased to be able to recommend fluocinolone (ILUVIEN) for
some people for the treatment of this condition in draft guidance.” NICE will
issue final guidance after a comment period.

“We are encouraged by Alimera’s optimism that this recommendation will result
in a change in the final published NICE guidance and by Alimera’s plans to
continue to work with NICE to seek to broaden access to ILUVIEN to include all
chronic DME patients who could benefit from the treatment,” added Dr. Ashton.

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 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 posterior

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 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.; 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.

Follow pSivida on social media:





The President's Blog:


Martin E. Janis & Company, Inc
Beverly Jedynak
Tel: +1 (312) 943 1123
pSivida Corp.
Brian Leedman
Vice President, Investor Relations
Tel: +61 (0) 41 228 1780
Press spacebar to pause and continue. Press esc to stop.