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

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

  PR Newswire

  ATLANTA, Jan. 17, 2013

ATLANTA, Jan. 17, 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 the Spanish Agency of Drugs and Medical Devices (Agencia
Espanola de Medicamentos y Productos Sanitarios) 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.

This marketing authorization follows the completion of the Decentralized
Regulatory Procedure (DCP) in the European Union (EU), in which the Medicines
and Healthcare products Regulatory Agency (MHRA) in the United Kingdom,
serving as the Reference Member State (RMS), delivered a positive outcome for
ILUVIEN along with six Concerned Members States (CMS), specifically Austria,
France, Germany, Italy, Portugal and Spain. The Spanish authorization is the
sixth national approval in the EU, preceded by Austria, the United Kingdom,
Portugal, France and Germany.

"ILUVIEN has now been granted marketing authorizations in six of the seven EU
countries in which we have applied," said Dan Myers, president and chief
executive officer, Alimera. "With our European management team now on board,
we are looking forward to the initial commercial launch of ILUVIEN in Germany,
expected during the first quarter of 2013. In addition, we continue to work
closely with the Italian regulatory authorities to secure marketing
authorization in Italy."

The International Diabetes Federation estimates that more than 3 million
people are currently living with diabetes in Spain, approximately 160,000 of
whom Alimera estimates suffer from vision loss associated with DME.

ILUVIEN is Alimera's sustained release intravitreal implant that delivers
sub-microgram levels of fluocinolone acetonide (FAc) for up to 36 months for
the treatment of chronic DME. The clinical trial data showed that in patients
with chronic DME at month 30, after receiving the ILUVIEN implant, 38 percent
of patients experienced an improvement from baseline in their best corrected
visual acuity on the Early Treatment of Diabetic Retinopathy Study (ETDRS) eye
chart of 15 letters or more. At the completion of the 36-month study, 34
percent had achieved the same result. This effect was highly statistically
significant as compared to the sham control group, which received laser and
other intravitreally administered therapies.

"As ophthalmologists, we've been limited in our ability to provide relief for
chronic diabetic macular edema patients when existing therapies have stopped
working," said José Maria Ruiz Moreno, professor of Ophthalmology, University
of Castilla La Mancha. "With its approval, ILUVIEN covers an important gap in
the range of treatment options for chronic diabetic macular edema, and it
becomes a source of hope for patients who face the threat of blindness."


ILUVIEN (190 micrograms fluocinolone acetonide intravitreal implant in
applicator) is a sustained release intravitreal implant used to treat patients
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 Alimera's FAME™
Study, the most frequently reported adverse drug reactions included cataract
operation, cataract and increased ocular pressure.

About FAME ™ Safety

Safety was assessed among those patients treated with ILUVIEN who were in the
subgroup of patients with DME for three years or more and were considered to
have chronic DME. Intraocular pressure (IOP) increases to 30 millimeters of
mercury (mmHg) or greater at any time point were seen in 12.7% of these
patients by month 36, compared to 18.4% in the full ILUVIEN treated patient
population. By month 36, 3.6% of these patients had undergone an incisional
surgical procedure to reduce elevated IOP, compared to 4.8% in the full
patient population. The incidence of cataracts among patients with a natural
lens in their eye at the start of the study was 84.1% at month 36, with 87.3%
undergoing a cataract operation, compared to 81.7% and 80.0%, respectively, in
the full patient population.

About DME

DME, the primary cause of vision loss associated with diabetic retinopathy, is
a disease affecting the macula, the part of the retina responsible for central
vision. When the blood vessel leakage of diabetic retinopathy causes swelling
in the macula, the condition has progressed to DME. The onset of DME is
painless and may go undetected by the patient until it manifests with the
blurring of central vision or acute vision loss. The severity of this blurring
may range from mild to profound loss of vision. As the population of people
with diabetes increases, it is anticipated that the annual incidence of
diagnosed DME will increase.

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 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 EU. 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, 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 .
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

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