Alimera Sciences' ILUVIEN® Receives Marketing Authorization In Norway For The Treatment Of Chronic Diabetic Macular Edema

Alimera Sciences' ILUVIEN® Receives Marketing Authorization In Norway For The
                 Treatment Of Chronic Diabetic Macular Edema

Portugal approves reimbursement for ILUVIEN

PR Newswire

ATLANTA, July 28, 2014

ATLANTA, July 28, 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 the Norwegian Medicines Evaluation Board has granted
marketing authorization to ILUVIEN® for the treatment of vision impairment
associated with chronic diabetic macular edema (DME) considered insufficiently
responsive to available therapies.

Norway is the first country to grant national marketing authorization
following the positive outcome in June of the Repeat-Use Procedure
application. In addition to Norway, ILUVIEN is now approved for marketing in
Austria, France, Germany, Italy, Portugal, Spain and theUnited Kingdom, and
is commercially available in the United Kingdom and Germany. ILUVIEN is
pending approval in an additional nine countries included in the Repeat-Use
Procedure. These countries are Belgium, the Czech Republic, Denmark, Finland,
Ireland, Luxembourg, the Netherlands, Poland and Sweden. ILUVIEN is currently
under review by the U.S. Food and Drug Administration.

Additionally, ILUVIEN has been approved for reimbursement in Portugal by
INFARMED, the marketing authorization body of the Portuguese Ministry of
Health. Alimera plans to move forward with commercialization in Portugal in
late 2014.

"With marketing approval in Norway and reimbursement approval in Portugal,
ILUVIEN is gaining traction across Europe," said Dan Myers, Alimera's
president and chief executive officer. "We are committed to providing
widespread patient access to this effective, long-term treatment."

About the Mutual Recognition Procedure

In the Mutual Recognition Procedure, a medicine is first authorized in one
European Union Member State, in accordance with the national procedures of
that country. A Marketing Authorization Holder can use the MRP for the same
authorization more than once after completion of a first decentralized
procedure (DCP) and obtain marketing authorization in other Member
States.According to the European Commission Directive guidance, this is known
as Repeat-Use, and is a procedure where those Member States, not involved in
the first DCP, agree to recognize the validity of the original, national
marketing authorization. The initial ILUVIEN DCP resulted in marketing
authorizations in Austria, France, Germany, Italy, Portugal, Spain and
theUnited Kingdom. ILUVIEN is currently commercially available in the United
Kingdom and Germany.

About ILUVIEN^®

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, a phase 3 clinical
study of ILUVIEN, the most frequently reported adverse drug reactions included
cataract development and increased ocular pressure. ILUVIEN has not been
approved for sale in the United States.

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. For more information, please visit
www.alimerasciences.com.

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, the regulatory status and potential commercialization of ILUVIEN
in Norway and the nine additional EU countries for which Alimera has applied
for approval, and the pending commercialization in Portugal. 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 EU, Alimera's ability to obtain marketing authorization for
ILUVIEN in additional EU countries, 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, 2013 and Quarterly Report on Form
10-Q for the quarter ended March 31, 2014, 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, FleishmanHillard 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.