Alimera Sciences Receives Complete Response Letter For ILUVIEN®

       Alimera Sciences Receives Complete Response Letter For ILUVIEN®

Alimera Continues Focus on European Growth

PR Newswire

ATLANTA, Oct. 18, 2013

ATLANTA, Oct. 18, 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 it has received a Complete Response Letter (CRL) for the
New Drug Application (NDA) for ILUVIEN® from the U.S. Food and Drug
Administration (FDA).

Identifying concerns regarding the benefit to risk and safety profiles of
ILUVIEN, the FDA stated that the NDA could not be approved in its present
form. To address the clinical and statistical deficiencies identified, the
FDA indicated that results from a new clinical trial would need to be
submitted, together with at least 12 months of follow-up for all enrolled
patients. The FDA suggested that a meeting with the Dermatologic and
Ophthalmic Drugs Advisory Committee may be of assistance in addressing the
deficiencies identified above and providing advice whether a patient
population can be identified in which the benefits of the drug product might
outweigh the risks. In a separate written communication from the staff of the
FDA, Alimera was notified that an Advisory Committee meeting would be convened
on January 27, 2014.

In the CRL, the FDA also referenced deficiencies at the facility where ILUVIEN
is manufactured. Alimera does not believe that these deficiencies will affect
its European commercial supply.

"The FDA's decision not to approve ILUVIEN at this time is disappointing not
only to us, but also to retinal specialists and DME patients in the U.S., but
we will continue to work with the FDA, through the advisory committee, to
determine whether there is a path forward in the U.S. for ILUVIEN," said Dan
Myers, president and chief executive officer of Alimera. "We remain excited
about Europe, however, where we have aligned our energy and resources to
support the expansion of our business there. Our current traction in the
countries in which ILUVIEN has already been approved, coupled with our
continued pursuit of further country approvals, should position us well for
future growth, irrespective of the U.S. outcome."

Alimera's commercial focus is on Europe, where the product is approved and
commercially available in the United Kingdom and Germany and slated to launch
in France early next year. ILUVIEN is also approved in Austria, Portugal and
Spain and pending approval in Italy. In addition, Alimera has filed with the
Medicines and Healthcare Products Regulatory Agency in the United Kingdom
(U.K.) as the Reference Member State for 10 additional European Union country
approvals through the Mutual Recognition Procedure.


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 for sale in the U.S.

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.

About the Mutual Recognition Procedure

The Mutual Recognition Procedure is a procedure used by pharmaceutical
companies to expand marketing authorization into additional countries in the
European Union (EU). A company that has been granted a marketing authorization
for selling pharmaceuticals in one EU member state can use this procedure to
request that same authorization in other member states. The Reference Member
State's assessment report forms the basis for requesting the other member
states' mutual recognition of the marketing authorization including the
Summary of Product Characteristics, package leaflet and labeling text. A
member state may disagree with the assessment report on the basis that it
feels the product creates a potentially serious risk to public health.

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 extent of the commercial availability and funding of ILUVIEN
in the United Kingdom, Germany and France, the regulatory status of ILUVIEN in
the EU, and Alimera's plans for ILUVIEN in the U.S. 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 publication of final
guidance, uncertainty as to Alimera's ability to commercialize, and market
acceptance of, ILUVIEN in the United Kingdom and Germany, 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 June 30, 2013, which are
on file with the Securities and Exchange Commission (SEC) and available on the
SEC's website at 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
404-739-0150                       310-954-1105

SOURCE Alimera Sciences, Inc.

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