Alimera Sciences' ILUVIEN® Receives Marketing Authorization In Italy For The
Treatment Of Chronic Diabetic Macular Edema
ATLANTA, June 23, 2014
ATLANTA, June 23, 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 Italian Medicines Agency (Agenzia Italiana del
Farmaco) 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.
The ILUVIEN marketing authorization notice was published on June 18 in the
Gazzetta Ufficiale della Repubblica Italiana, the official journal of record
of the Italian government. Designated a C Class product in Italy, ILUVIEN will
be available initially to private paying patients. Alimera is pursuing H Class
designation for ILUVIEN with the Italian regulatory authorities, which, if
granted, would expand patient access to the product.
The Italian authorization is the seventh national approval in the EU, preceded
by Austria, theUnited Kingdom, Portugal, France, Germany and Spain. ILUVIEN
is commercially available in the U.K. and Germany.
"ILUVIEN has now been granted marketing authorizations in all seven EU
countries in which we initially applied," said Dan Myers, Alimera's president
and chief executive officer. "Additionally, we are engaged in a Repeat Use
Procedure through Mutual Recognition (MRP) to obtain a positive opinion for
approval from another10 EU countries."
"This approval is important news for patients in Italy with DME whose disease
has evolved to chronic DME," said Dr. Stanislao Rizzo, chairman of the U. O.
Chirurgia Oftalmica, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.
"ILUVIEN is a valuable option for patients who are not sufficiently responding
to other treatments."
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.
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 Italy and the 10 additional EU countries for which Alimera has applied for
approval. 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
For press inquiries: For investor inquiries:
Katie Brazel, FleishmanHillard John Mills, ICR
for Alimera Sciences for Alimera Sciences
SOURCE Alimera Sciences, Inc.
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