Alimera Sciences Announces First Patient Treated With Commercially Available ILUVIEN®

 Alimera Sciences Announces First Patient Treated With Commercially Available

ILUVIEN now available in Germany as a new treatment for chronic diabetic
macular edema

PR Newswire

ATLANTA, May 7, 2013

ATLANTA, May 7, 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 ILUVIEN^®, the first sustained release pharmaceutical
product for the treatment of chronic diabetic macular edema (DME), is now
commercially available in Germany.

In addition, Albert J. Augustin, M.D., professor and chairman of the
Department of Ophthalmology, Klinikum Karlsruhe, Karlsruhe, Germany, has
treated the world's first patient with the implant injection since the product
became commercially available. The patient, a 67-year-old man, was diagnosed
with diabetes more than 20 years ago.

"We are honored to be the first hospital to offer this new sustained release
treatment to those suffering from vision impairment associated with chronic
diabetic macular edema considered insufficiently responsive to available
therapies," said Dr. Augustin. "ILUVIEN brings hope to many patients in
Germany affected by this sight-robbing disease."

"We are very pleased that patients throughout Germany struggling with this
devastating disease can now be treated with ILUVIEN," said Dan Myers,
Alimera's president and chief executive officer. "Now chronic DME patients in
both Germany and the United Kingdom have a long-acting, sustained release
treatment option available to help improve their visual acuity."

About DME

Diabetic macular edema (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
the annual incidence of diagnosed DME will increase.


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 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 United Kingdom
(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, Spain and Germany have granted national licenses
for ILUVIEN. ILUVIEN has not been approved by the United States Food and Drug

Clinical trial data from the FAME Study 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 (p
< 0.001) as compared to the control group, which received laser and other
intravitreally administered therapies. 

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, the commercialization of ILUVIEN in Germany, the United Kingdom
and other jurisdictions in the European Union. 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 Germany, the
United Kingdom and other jurisdictions in the European Union, 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,
which is on file with the Securities and Exchange Commission (SEC) and
available on the SEC's website at Additional factors may also be
set forth in those sections of Alimera's Quarterly Report on Form 10-Q for the
quarter ended March 31, 2013 to be filed with the SEC in the second quarter of
2013. 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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