Alimera Sciences, Inc
ATLANTA, Jun 29, 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
New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for
Iluvien(R), (flucocinolone acetonide intravitreal insert), its investigational,
sustained drug delivery system releasing sub-microgram levels of fluocinolone
acetonide for the treatment of diabetic macular edema (DME). In the
submission, Alimera requested priority review, which, if granted, could
result in an action letter from the FDA in the fourth quarter of 2010.
"This is a significant milestone for all of us at Alimera,
and represents a major advance toward a rapid and sustained visual acuity
benefit for DME sufferers," said Dan Myers, president and CEO of
Alimera, adding, "We believe that Iluvien(R), if approved, will provide
a needed alternative to the multiple injections of corticosteroids and
anti-VEGF therapies used off-label for extended efficacy in DME. We believe
this would be the first ophthalmic drug therapy to be approved for DME and
the only DME treatment that works in terms of years, not months."
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. The 24-month clinical readout from the study was
completed and announced in December 2009.
This NDA submission includes the 24-month low dose data from the
FAME Study. Alimera plans to follow this NDA submission with registration
filings in certain European countries and 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. Based on this study and the current U.S. diabetic population, Alimera
estimates that there will be an incidence of approximately 340,000 cases of DME
annually in the United States. 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: Fleishman-Hillard for Alimera Sciences
Katie Brazel
404-739-0150
[email protected]