WATERTOWN, Mass.--(BUSINESS WIRE)--
pSivida Corp. (NASDAQ:PSDV)
(ASX:PVA), a leader in developing sustained release, drug delivery
products for treatment of back-of-the-eye diseases, announced today that
the United Kingdom's National Institute for Health and Clinical
Excellence (NICE) has accepted for review additional data relating to
the pseudophakic subgroup of patients with chronic diabetic macular
edema (DME), meaning those patients who already had cataract surgery and
had received an artificial lens when they entered the FAME™ Study
conducted by pSivida's licensee, Alimera Sciences, Inc. (Alimera). NICE
is currently evaluating the cost-effectiveness of ILUVIEN for the
treatment of chronic DME considered insufficiently responsive to
available therapies.
Alimera reported that the additional data was included in an appendix to
its comments on the preliminary Appraisal Consultation Document (ACD) of
NICE's Appraisal Committee issued in August for the ILUVIEN Single
Technology Appraisal (STA). Alimera reported that according to NICE's
Guide to the STA, new data are only accepted if they are likely to
affect the provisional recommendations in the ACD. In the provisional
recommendations published in August, NICE proposed not to recommend the
use of ILUVIEN to the U.K. National Health Service.
Alimera said that the Second Appraisal Committee meeting, previously
scheduled for September 11, 2012, was rescheduled to October 11, 2012
because NICE informed Alimera that the Appraisal Committee required
adequate time to thoroughly review the additional data.
Alimera reported that it determined that ILUVIEN was more cost-effective
in the pseudophakic patient subgroup of the FAME Study. Because patients
with artificial lenses cannot develop another cataract in the treated
eyes due to their exposure to the corticosteroid delivered via ILUVIEN,
they will not experience the transient reduction in visual acuity as the
result of cataract development that occurred in some patients during the
first two years of the FAME Study, nor will they incur the cost
associated with cataract surgery.
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 Macular Edema (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.
The United States Food and Drug Administration (FDA) has cleared
pSivida's Investigational New Drug application (IND) to treat posterior
uveitis with the same micro-insert. An investigator-sponsored clinical
trial is ongoing for an injectable, bioerodible 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: inability to
predict whether NICE will recommend ILUVIEN for treatment of chronic DME
patients at all or for a subgroup, no assurance that Alimera will
resubmit its application or be able to demonstrate to the FDA that the
benefits outweigh the risks of ILUVIEN for DME using data from their two
previously completed pivotal Phase III clinical trials (FAME™ Study),
that additional clinical trials will not be required, that the
population of chronic DME patients will be acceptable to the FDA or that
Alimera will be able to obtain regulatory approval for ILUVIEN for DME
in the U.S.; ability of Alimera to consummate its pending financing; the
timing and conditions for additional regulatory approvals are subject to
decisions by regulators; necessity to raise additional capital to
finance Phase III uveitis trials as well as other working capital needs;
ability to obtain additional capital; ability to initiate and complete
clinical trials and obtain regulatory approval of product candidates;
adverse side effects; Alimera's ability to successfully obtain
regulatory approval of and commercialize ILUVIEN for DME in the EU;
actions with respect to regulatory approval of ILUVIEN for DME in the
U.S.; ability to attain profitability; exercise by Pfizer, Inc. of the
Latanoprost Product option; further impairment of intangible assets;
fluctuations in operating results; decline in royalty revenues; ability
to find partners to develop and market products; termination of license
agreements; competition; market acceptance of products and product
candidates; reduction in use of products as a result of future
guidelines, recommendations or studies; ability to protect intellectual
property and avoid infringement of others' intellectual property;
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; ability to pay
any registration penalties; 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.
IN US:
Martin E. Janis & Company, Inc.
Beverly Jedynak,
312-943-1123
President
bjedynak@janispr.com
or
In
Australia:
pSivida Corp.
Brian Leedman, +61 (0) 41 228 1780
Vice
President, Investor Relations
brianl@psivida.com
Source: pSivida Corp.
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