pSivida Corp. Reports Patient Access Scheme Being Developed by Alimera to Address Cost Concerns Following Negative Final Draft

  pSivida Corp. Reports Patient Access Scheme Being Developed by Alimera to
  Address Cost Concerns Following Negative Final Draft Guidance by U.K.’s NICE
  for ILUVIEN® for DME

Business Wire

WATERTOWN, Mass. -- November 30, 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 United Kingdom’s National Institute for Health and
Clinical Excellence (NICE) issued final draft guidance indicating that ILUVIEN
is not recommended for the treatment of chronic diabetic macular edema (DME)
considered insufficiently responsive to available therapies. While ILUVIEN has
received marketing authorization in the U.K., the independent Appraisal
Committee concluded that the evidence provided did not show that the benefits
ILUVIEN provides to patients justify the proposed price.

pSivida’s licensee, Alimera Sciences, reported that in response to the final
draft guidance, it has immediately begun to develop a Patient Access Scheme
(PAS) to address NICE’s cost concerns. According to Alimera, the PAS being
developed, if accepted, will make ILUVIEN available to all chronic DME
patients in the United Kingdom considered insufficiently responsive to
available therapies.

The International Diabetes Federation estimates that more than 3 million
people are currently living with diabetes in the U.K., nearly 200,000 of whom,
according to Alimera’s estimates, suffer with vision loss from 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 and
the U.K. and is awaiting authorization in Italy and Spain. 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 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.

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: outcome of reimbursement for ILUVIEN in the U.K., 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; 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.


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