WATERTOWN, Mass.--(BUSINESS WIRE)--
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issued draft guidance recommending ILUVIEN® for the treatment of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 period.
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condition in draft guidance."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 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: 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:
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
Martin E. Janis & Company, Inc
Beverly Jedynak
President
Tel:
+1 (312) 943 1123
bjedynak@janispr.com
or
pSivida
Corp.
Brian Leedman
Vice President, Investor Relations
Tel:
+61 (0) 41 228 1780
brianl@psivida.com
Source: pSivida Corp.
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