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

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

Alimera Sciences continues to work on development of a Patient Access Scheme

PR Newswire

ATLANTA, Jan. 23, 2013

ATLANTA, Jan. 23, 2013 /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 published final guidance indicating that
ILUVIEN^® is not cost effective for the treatment of chronic diabetic macular
edema (DME) considered insufficiently responsive to available therapies. This
information is consistent with the final draft guidance issued on November 29,
2012 and does not take into account any potential for a patient access scheme
(PAS).

The NICE Appraisal Committee acknowledged the clinical effectiveness of
ILUVIEN in the treatment of vision impairment associated with chronic DME
considered insufficiently responsive to available therapies, but noted that
cost-effectiveness thresholds for the product have not yet been met. Rather
than appealing the Appraisal Committee's findings, Alimera has chosen to
pursue a simple PAS for ILUVIEN that is intended to allow treatment decisions
to be based on patient need, rather than cost. The PAS is currently under
review by the Patient Access Schemes Liaison Unit (PASLU) at NICE and, if
approved by the Department of Health, will be available to the Appraisal
Committee for review and consideration.

"Having anticipated this final guidance, we have developed a simple PAS that
we believe could be considered under NICE's rapid review facility should the
PAS be accepted. It is our hope that, if accepted, the PAS will make ILUVIEN
available to all chronic DME patients in England and Wales who are 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, six of the seven countries, Austria, the United Kingdom,
Portugal, France, Germany and Spain 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. Alimera Sciences Limited, a wholly
owned subsidiary of Alimera, is headquarters of Alimera's European operations
in London. 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,
uncertainty as to Alimera's ability to commercialize, and market acceptance
of, ILUVIEN in the United Kingdom, 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, 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 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
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
Katie.Brazel@fleishman.com      John.Mills@ICRINC.com

SOURCE Alimera Sciences, Inc.

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