Breaking News

French Planes Carry Out First Strikes on Iraq Islamic State Targets
Tweet TWEET

Alimera Sciences' ILUVIEN® Receives Final Draft Guidance From U.K.'s NICE

  Alimera Sciences' ILUVIEN® Receives Final Draft Guidance From U.K.'s NICE

Alimera Sciences to develop a Patient Access Scheme in response to negative
recommendation

PR Newswire

ATLANTA, Nov. 29, 2012

ATLANTA, Nov. 29, 2012 /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 the United Kingdom's National Institute for Health and
Clinical Excellence (NICE) has issued final draft guidance indicating that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 the
Appraisal Committee acknowledged the clinical effectiveness of ILUVIEN^® in
the treatment of vision impairment associated with chronic DME considered
insufficiently responsive to available therapies, it noted that
cost-effectiveness thresholds for the product have not yet been met.

In response to the final draft guidance, Alimera is now developing a Patient
Access Scheme (PAS) to address the Appraisal Committee's cost concerns that
pose a barrier to access for people in the United Kingdom with chronic DME who
might benefit from ILUVIEN. The goal of the PAS will be to determine the
appropriate pricing for ILUVIEN in order to ensure that treatment decisions
are based on patient need, rather than cost.

Andrew Lotery, Professor of Ophthalmology, University of Southampton, said, "I
am very pleased that NICE has recognized that ILUVIEN is clinically effective
for chronic diabetic macular oedema. I am hopeful that this sustained-release
therapy will become available to the thousands of people affected with
diabetes in the United Kingdom."

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.

"In recognition of the ongoing process with NICE, we have immediately begun to
develop a Patient Access Scheme which, if accepted, will make ILUVIEN
available to all chronic DME patients in the United Kingdom considered
insufficiently responsive to available therapies," said Dan Myers, president
and chief executive officer, Alimera.

About ILUVIEN^®

ILUVIEN (190 micrograms fluocinolone acetonide 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 operation, cataract and increased ocular pressure.

In July 2010, Alimera submitted a Marketing Authorization Application (MAA) to
seven European countries via the Decentralized Procedure (DCP) with the
Medicines and Healthcare products Regulatory Agency of the U.K. (MHRA) serving
as the Reference Member State (RMS). The MAA included data from two Phase 3
pivotal clinical trials (collectively known as the FAME™ Study) for ILUVIEN
conducted by Alimera. The trials involved 956 patients in sites across the
United States, Canada, Europe and India to assess the efficacy and safety of
ILUVIEN for the treatment of DME. At the end of the DCP, a consensus was
reached by the RMS and the other six countries that the MAA for ILUVIEN was
approvable. To date, five of the seven countries, Austria, the United Kingdom,
Portugal, France and Germany have granted national licenses for ILUVIEN.
ILUVIEN has not been approved by the United States Food and Drug
Administration.

About Alimera Sciences, Inc.

Alimera Sciences, Inc., based in Alpharetta, Georgia, is a biopharmaceutical
company that specializes in the research, development and commercialization of
prescription ophthalmic pharmaceuticals. Presently Alimera is focused on
diseases affecting the back of the eye, or retina. Its primary product,
ILUVIEN, is an intravitreal implant containing fluocinolone acetonide (FAc), a
non-proprietary corticosteroid with demonstrated efficacy in the treatment of
ocular disease.

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,
NICE's acceptance of the Patient Access Scheme, uncertainty as to Alimera's
ability to commercialize, and market acceptance of ILUVIEN in the United
Kingdom, and 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, 2011 and Quarterly Report on Form 10-Q for the quarter ended September 30,
2012, 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 theSEC,
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
otherwise.



For press inquiries:
                                For investor inquiries:
Katie Brazel, Fleishman-Hillard
                                John Mills, ICR
for Alimera Sciences
                                for Alimera Sciences
404-739-0150                    310-954-1105
                                 John.Mills@ICRINC.com
Katie.Brazel@fleishman.com



SOURCE Alimera Sciences, Inc.

Website: http://www.alimerasciences.com
 
Press spacebar to pause and continue. Press esc to stop.