Full Press Release Details
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| Katie Brazel, Fleishman-Hillard for Alimera Sciences 404-739-0150 Katie.Brazel@fleishman.com | John Mills, ICR for Alimera Sciences 310-954-1105 John.Mills@ICRINC.com |
ALIMERA SCIENCES RECEIVES COMPLETE
RESPONSE LETTER FROM FDA FOR ILUVIEN
Conference Call Scheduled for
Monday, November 14 at 8 a.m. Eastern Time
ATLANTA, November 11, 2011 -
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) from the U.S. Food
and Drug Administration (FDA) in response to the New Drug Application
(NDA) for ILUVIEN for the treatment of diabetic macular edema
(DME) associated with diabetic retinopathy.
A CRL is issued by the FDA's
Center for Drug Evaluation and Research when their review of an application is
completed and questions remain that precludes the approval of the NDA in its
The FDA stated that it was unable to
approve the ILUVIEN NDA because the NDA did not provide sufficient data to
support that ILUVIEN is safe and effective in the treatment of patients with
DME. The FDA stated that the risks of adverse reactions shown for ILUVIEN in
the FAME Study were significant and were not offset by the benefits
demonstrated by ILUVIEN in these clinical trials. The FDA has indicated
that Alimera will need to conduct two additional clinical trials to demonstrate
that the product is safe and effective for the proposed indication.
The Company will be requesting a
meeting with the FDA to clarify next steps.
ILUVIEN is Alimera's
investigational, sustained drug delivery system that releases sub-microgram
levels of fluocinolone acetonide (FAc) for the treatment of DME. In
December 2010, the FDA issued a CRL to Alimera related to its
June 2010 NDA for ILUVIEN, which included data through month 24 of the
FAME Study. In that first CRL, the FDA asked for, among other things,
analyses of the safety and efficacy data through month 36 of the FAME Study.
Alimera submitted a response to the FDA on May 12, 2011, addressing the
issues raised in the first CRL and including 36-month trial data. The FDA
classified Alimera's response as a Class 2 resubmission, resulting
in a six-month review period and a Prescription Drug User Fee Act, or PDUFA,
date of November 12, 2011.
"We are surprised and
disappointed with the FDA's decision on our application to market ILUVIEN
in the U.S. to patients with this devastating disease. Based on extensive
research with U.S. retinal physicians, we have learned that ILUVIEN's
long-term sustained delivery treatment benefit is desired and that ILUVIEN has
a manageable risk to benefit ratio. We continue to believe in ILUVIEN as a
long-term effective treatment option for DME. We are committed to, and have the
funds for, pursuing approval in Europe and for evaluating our options in the
U.S.," said Dan Myers, president and chief executive officer of Alimera.
For Europe, Alimera expects to submit
its formal response to the Preliminary Assessment Report to the Medicines and
Healthcare products Regulatory Agency (MHRA) later this month. Based on
this submission, the MHRA is expected to make a recommendation on the
approvability of ILUVIEN to Alimera and the Concerned Member States (Austria,
France, Germany, Italy, Portugal and Spain) by the end of this year, with a
decision regarding the approval of ILUVIEN expected in the first half of 2012.
The market opportunity in Europe is similar in size to the U.S. market
Conference Call to be Held Monday
Alimera has scheduled a conference call
for Monday, November 14 at 8:00 a.m. ET to discuss the FDA's
response. The conference call will be hosted by Dan Myers, president and chief
executive officer, and Rick Eiswirth, chief operating officer and chief
To participate in the call, please dial
(877) 369-6586 (U.S. and Canada) or (253) 237-1165 (international). A
live webcast will be available on the Investor Relations section of
Alimera's corporate website at http://www.alimerasciences.com.
A replay of the conference call will be
available beginning November 14, 2011 at 11:00 a.m.ET and ending on
November 28, 2011 by dialing (855) 859-2056 (U.S. and Canada) or
(404) 537-3406 (international), Conference ID Number: 27995219. A replay
of the webcast will be available on the corporate website for two weeks,
through November 28, 2011.
ILUVIEN is an investigational, extended
release intravitreal insert that Alimera is developing for the treatment of
DME. Each ILUVIEN insert is designed to provide a therapeutic effect of up to
36 months by delivering sustained sub-microgram levels of the
corticosteroid fluocinolone acetonide (FAc). ILUVIEN is inserted in the back of
the patient's eye to a position that takes advantage of the eye's
natural fluid dynamics. The insertion device employs a 25-gauge needle, which
allows for a self-sealing wound.
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 advanced product candidate, ILUVIEN, is an intravitreal
insert containing fluocinolone acetonide (FAc), a non-proprietary
corticosteroid with demonstrated efficacy in the treatment of ocular disease.
ILUVIEN is in development for the treatment of DME, a disease of the retina
that affects individuals with diabetes and can lead to severe vision loss and
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 future results of operations and financial position, business
strategy and plans and objectives of management for Alimera's future
operations. Words such as "anticipate," "believe,"
"estimate," "expect," "intend,"
"may," "plan," "predict,"
"project," "target," "likely,"
"potential," "continue," "will,"
"would," "should," "could," or the negative