Alimera Sciences Ships First ILUVIEN® Orders For U.K. National Health Service
First NHS patient treated less than seven weeks following NICE published
ATLANTA, Jan. 13, 2014
ATLANTA, Jan. 13, 2014 /PRNewswire/ --Alimera Sciences, Inc. (NASDAQ: ALIM)
(Alimera), a biopharmaceutical company that specializes in the research,
development and commercialization of prescription ophthalmic pharmaceuticals,
today announced that it has begun shipping initial orders of ILUVIEN® to
several United Kingdom National Health Service (NHS) facilities. Additionally,
on January 10, 2014, the first NHS patient received an ILUVIEN implant for the
treatment of chronic diabetic macular edema (DME).
In November 2013, the U.K.'s National Institute for Health and Care Excellence
(NICE) published final guidance for ILUVIEN, clearing the path to patient
availability through the NHS. NICE requires clinical commissioning groups, NHS
England and local public health authorities to comply with the recommendations
in the final guidance within three months of its date of publication. The
January orders of ILUVIEN indicate an early implementation of the NICE
guidance in certain NHS facilities.
"It is very exciting to be able to provide a patient with ILUVIEN," said Miss
Sudeshna Patra, consultant ophthalmic surgeon, who treated the first NHS
patient with ILUVIEN at Whipps Cross University Hospital, London, run by Barts
Health NHS Trust, the largest NHS Trust in the U.K. "With ILUVIEN, patients
who have chronic diabetic macular edema insufficiently responsive to other
therapies may now benefit from 36 months of sustained intravitreal steroid
treatment. ILUVIEN has the potential to greatly improve the quality of life of
these diabetic patients, who are at risk of severe sight impairment if left
The NICE final guidance states that patients with a pseudophakic eye, meaning
the eye has already undergone cataract surgery, are eligible to receive
ILUVIEN for the treatment of chronic DME considered insufficiently responsive
to available therapies.
"We believe that the speed at which ILUVIEN has been made available at certain
NHS facilities is indicative of the unmet need in this chronic DME patient
population," said Dan Myers, Alimera's president and chief executive officer.
"These patients now have a new, effective treatment available to them."
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. In the FAME™ Study, the most frequently
reported adverse drug reactions included cataract development and increased
ocular pressure. ILUVIEN has not been approved by the United States Food and
About Alimera Sciences, Inc.
Alimera Sciences, Inc., headquartered in Alpharetta, Georgia, is a
biopharmaceutical company that specializes in the research, development and
commercialization of prescription ophthalmic pharmaceuticals. Alimera's
European operations are conducted from London by its wholly-owned subsidiary,
Alimera Sciences Limited.
Forward Looking Statements
This press release contains "forward-looking statements," within the meaning
of the Private Securities Litigation Reform Act of 1995, regarding, among
other things, Alimera's commercial plans for ILUVIEN in the United Kingdom.
Such forward-looking statements are based on current expectations and involve
inherent risks and uncertainties, including factors that could delay, divert
or change any of them, and could cause actual results to differ materially
from those projected in its forward-looking statements. Meaningful factors
which could cause actual results to differ include, but are not limited to the
speed with which other NHS facilities implement the NICE guidance, as well as
other factors discussed in the "Risk Factors" and "Management's Discussion and
Analysis of Financial Condition and Results of Operations" sections of
Alimera's Annual Report on Form 10-K for the year ended December 31, 2012 and
Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, which
are on file with the Securities and Exchange Commission (SEC) and available on
the SEC's website at www.sec.gov. In addition to the risks described above and
in Alimera's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q,
Current Reports on Form 8-K and other filings with the SEC, other unknown or
unpredictable factors also could affect Alimera's results. There can be no
assurance that the actual results or developments anticipated by Alimera will
be realized or, even if substantially realized, that they will have the
expected consequences to, or effects on, Alimera. Therefore, no assurance can
be given that the outcomes stated in such forward-looking statements and
estimates will be achieved.
All forward-looking statements contained in this press release are expressly
qualified by the cautionary statements contained or referred to herein.
Alimera cautions investors not to rely too heavily on the forward-looking
statements Alimera makes or that are made on its behalf. These forward-looking
statements speak only as of the date of this press release (unless another
date is indicated). Alimera undertakes no obligation, and specifically
declines any obligation, to publicly update or revise any such forward-looking
statements, whether as a result of new information, future events or
For press inquiries: For investor inquiries:
Katie Brazel, Fleishman-Hillard John Mills, ICR
for Alimera Sciences for Alimera Sciences
SOURCE Alimera Sciences, Inc.
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