Alimera Sciences, Inc.
ATLANTA, Jul 8, 2010 (GlobeNewswire via COMTEX News Network) -- Alimera
Sciences, Inc., (Nasdaq:ALIM), ("Alimera"), a biopharmaceutical
company that specializes in the research, development and commercialization
of prescription ophthalmic pharmaceuticals has submitted a Marketing
Authorization Application (MAA) to the Medicines and Healthcare products
Regulatory Agency (MHRA) in the United Kingdom (UK) for Iluvien(R)
(fluocinolone acetonide intravitreal insert). Iluvien(R) is Alimera's
investigational, sustained drug delivery system that releases sub-microgram
levels of fluocinolone acetonide for the treatment of diabetic macular edema
(DME). The MAA is being submitted through the Decentralized Procedure with
the UK MHRA as the Reference Member State (RMS). Applications have also been
submitted to the following other Concerned Member States (CMS) in the
European Union: Austria, France, Germany, Italy, Portugal and Spain.
"This MAA submission closely follows the submission of our
NDA to the U.S. Food and Drug Administration last week, and marks an
important first step toward the availability of a sustained release treatment
for DME patients in Europe," said Dan Myers, president and CEO of
Alimera. "We anticipate that Iluvien(R), if approved, will be welcomed
by physicians and patients alike as a much-needed, long-term alternative to
the multiple injections of corticosteroids and anti-VEGF therapies currently
used off-label for DME."
Alimera is currently conducting two Phase 3 pivotal clinical
trials (collectively known as the FAME Study) for Iluvien(R) involving 956
patients in sites across the United States, Canada, Europe and India to
assess the efficacy and safety of Iluvien(R) with two doses, a high and low
dose, for the treatment of DME. The primary efficacy endpoint for the FAME
Study is the difference in the percentage of patients whose best corrected
visual acuity (BCVA) improved by 15 or more letters from baseline on the ETDRS
eye chart at month 24 between the treatment and control groups. The study
will conclude later this year with the final patient visits at the three-year
data point.
This MAA submission includes the 24-month low dose data from the
FAME Study. In December 2009, the 24-month clinical readout from the FAME
Study was completed and announced. Alimera plans to follow this MAA
submission with a registration filing in Canada in the near future
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 is called 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. The
Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a
10-year period approximately 19% of diabetics studied were diagnosed with
DME. As the population of people with diabetes increases, Alimera expects the
annual incidence of diagnosed DME to increase, as well.
About Iluvien(R)
Iluvien(R) is an investigative, extended release intravitreal
insert that Alimera is developing for the treatment of DME. Each Iluvien(R)
insert is designed to provide a therapeutic effect of up to 36 months by
delivering sustained sub-microgram levels of fluocinolone acetonide (FA).
Iluvien(R) 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 the
Company is focused on diseases affecting the back of the eye, or retina. Its
advanced product candidate Iluvien(R) is an intravitreal insert containing
fluocinolone acetonide, a non-proprietary corticosteroid with demonstrated
efficacy in the treatment of ocular disease. Iluvien(R) is in development for
the treatment of diabetic macular edema (DME), a disease of the retina that
affects individuals with diabetes and can lead to severe vision loss and
blindness.
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," "likely,"
"will," "would," "could," and similar
expressions are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words. The events
and circumstances reflected in Alimera's forward-looking statements may not
occur and actual results could 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, delay in or failure to
obtain regulatory approval of Alimera's product candidates, uncertainty as to
Alimera's ability to commercialize, and market acceptance of, its product
candidates, the extent of government regulations, uncertainty as to
relationship between the benefits of Alimera's product candidates and the
risks of their side-effect profiles, dependence on third-party manufacturers
to manufacture Alimera's product candidates in sufficient quantities and
quality, uncertainty of clinical trial results, limited sales and marketing
infrastructure, as well as other factors discussed in Alimera's Securities
and Exchange Commission filings, including Alimera's quarterly report on Form
10-Q for the quarter ended March 31, 2010 filed with the Securities and
Exchange Commission.
All forward-looking statements contained in this press release
are expressly qualified by the above paragraph in their entirety. 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 otherwise.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Alimera Sciences, Inc.
CONTACT: Alimera Sciences
Katie Brazel, Fleishman-Hillard
404-739-0150
[email protected]