Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a leader in the
commercialization, research, and development of prescription
ophthalmic pharmaceuticals, today announced that patients are now
being treated in Italy with ILUVIEN, its sustained release
intravitreal implant that is indicated in Europe for the treatment
of vision impairment associated with chronic diabetic macular edema
(DME).
ILUVIEN is designated a Class H product in Italy and, as such,
is hospital-administered and fully reimbursed for those patients
who have previously undergone cataract surgery.
“Italy is an important market for ILUVIEN as it has Europe's
fourth largest diabetes population1 and a medical community
that regularly uses corticosteroids to treat eye diseases,” said
Dan Myers, Alimera’s chief executive officer. “We look forward to
hearing from a growing number of Italian retinal specialists and
their patients about the benefits of having a product that treats
DME consistently every day due to its continuous microdosing, for
up to three years.”
ILUVIEN is distributed throughout Italy, San Marino and Vatican
City by Societa Industria Farmaceutica Italiana (SIFI), which also
handles all promotion, marketing and commercial activities in those
territories for ILUVIEN.
“At SIFI, we have focused on offering therapeutic solutions to
serious ocular problems for more than 80 years,” said Fabrizio
Chines, executive chairman of SIFI SpA. “As we prepared to launch
ILUVIEN in Italy, we found that our physicians were eagerly
anticipating its availability as it represents a real innovation in
DME treatment. By providing a consistent daily dose with one
injection over three years, ILUVIEN has the potential to greatly
improve patient convenience and adherence to therapy, which
naturally lead to better results.”
About ILUVIEN
www.ILUVIEN.com
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is
a sustained release intravitreal implant indicated in the E.U. to
treat vision impairment associated with chronic DME considered
insufficiently responsive to available therapies. Each ILUVIEN
implant with its continuous microdosing is designed to release
submicrogram levels of fluocinolone acetonide, a corticosteroid,
for 36 months, enabling the physician to treat the disease
consistently every day.
About Diabetic Macular Edema (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 associated with diabetic retinopathy results in swelling of
the macula, the condition is called DME. The onset of DME is
painless and may go unreported 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 people with
diabetes included in the study were diagnosed with DME. All people
with type 1 or type 2 diabetes are at risk of developing DME.
About Alimera Sciences, Inc.
www.alimerasciences.com
Alimera, founded in June 2003, is a pharmaceutical company
that specializes in the commercialization, research, and
development of prescription ophthalmic pharmaceuticals. Alimera is
presently focused on diseases affecting the back of the eye, or
retina, because these diseases are not well treated with current
therapies and will affect millions of people in our aging
populations. Alimera’s commitment to retina specialists and their
patients is manifest in Alimera’s product and development portfolio
designed to treat early- and late-stage diseases. For more
information, please visit www.alimerasciences.com.
About SIFI
SIFI is the leading Italian ophthalmic company, focused on
eye care since 1935. SIFI designs, manufactures and
markets innovative pharmaceutical specialty products, surgical and
medical devices. Headquartered in Catania, Sicily, SIFI
operates directly in Italy, Romania and Mexico with a staff of over
370 people worldwide. Since June 2015, SIFI is
backed by 21 Investimenti, the private equity firm founded
by Alessandro Benetton and leader in the Italian
mid-market, to support the company's international expansion and
portfolio development strategy. For more information, please
visit www.sifigroup.com.
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 potential of ILUVIEN to
improve patient convenience and adherence to therapy. 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, SIFI’s
ability to adequately promote, market and support ILUVIEN and the
degree to which physicians in Italy will use ILUVIEN to treat their
DME patients, 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, 2016 and
Quarterly Report on Form 10-Q for the quarter ended March 31,
2017, which are on file with the Securities and Exchange
Commission (SEC) and available on the SEC’s website
at www.sec.gov. Additional factors may be set forth in those
sections of Alimera's Quarterly Report on Form 10-Q for the quarter
ended June 30, 2017, to be filed in the third quarter of 2017 with
the SEC. 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 otherwise.
____________________
1 International Diabetes Federation. IDF Diabetes
Atlas, 7th edn. Brussels, Belgium: International Diabetes
Federation, 2015. http://www.diabetesatlas.org
For press inquiries:
Katie Brazel
for Alimera Sciences
404-317-8361
kbrazel@bellsouth.net
For investor inquiries:
CG Capital
for Alimera Sciences
877-889-1972
investorrelations@cg.capital
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