Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a pharmaceutical
company that specializes in the development and commercialization
of prescription ophthalmic pharmaceuticals, announces that ILUVIEN
is now available in Finland for diabetic macular edema (DME) and
non-infectious uveitis affecting the posterior segment (NIPU), and
will be marketed by Alimera and distributed by Nordic Prime.
“Finland marks the first of the Nordic countries that we have
now expanded into as part of our ongoing strategy to bring ILUVIEN
to patients around the world suffering from retinal disease,” said
Rick Eiswirth, Alimera’s President and Chief Executive Officer.
“This launch adds yet another territory to our commercial
footprint, with ILUVIEN now marketed in 13 countries. ILUVIEN
therapy delivers a daily treatment for up to three years, unlike
competing therapies that are acute, short-term therapies that need
to be reinjected into the eye every 1-3 months. The
durability of ILUVIEN can reduce the recurrence of symptoms in
patients with DME and non-infectious uveitis affecting the
posterior segment, and enable patients to see better, longer with
fewer injections.”
ILUVIEN is a sustained release intravitreal implant indicated in
several European countries for the treatment of vision impairment
associated with chronic diabetic macular edema (DME) considered
insufficiently responsive to available therapies and for
prevention of relapse in recurrent non-infectious uveitis affecting
the posterior segment of the eye (NIPU).
About ILUVIEN
www.ILUVIEN.com
The Company’s primary product is ILUVIEN (fluocinolone acetonide
intravitreal implant) 0.19 mg sustained release intravitreal
implant, injected into the back of the eye. With its CONTINUOUS
MICRODOSING™ technology, ILUVIEN is designed to release
sub-microgram levels of fluocinolone acetonide, a corticosteroid,
for 36 months, to reduce the recurrence of disease and number of
treatments required, enabling patients to maintain vision longer
with fewer injections. ILUVIEN is approved in the U.S., Canada,
Kuwait, Lebanon and the U.A.E to treat diabetic macular edema (DME)
in patients who have been previously treated with a course of
corticosteroids and did not have a clinically significant rise in
intraocular pressure. In 17 European countries, ILUVIEN is
indicated for the treatment of vision impairment associated with
chronic DME considered insufficiently responsive to available
therapies. In March 2019, ILUVIEN received approval in the 17
countries under the Mutual Recognition Procedure for prevention of
relapse in recurrent non-infectious uveitis affecting the posterior
segment of the eye. The 17 European countries include the U.K.,
Germany, France, Italy, Spain, Portugal, Ireland, Austria, Belgium,
Denmark, Norway, Finland, Sweden, Poland, Czechia, the Netherlands,
and Luxembourg. The non-infectious posterior uveitis indication for
ILUVIEN was launched in Germany and the U.K. in 3Q 2019. ILUVIEN is
not approved for treatment of uveitis in the United States.
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 Non-Infectious Posterior Uveitis
(NIPU)
Posterior segment non-infectious uveitis is a chronic,
inflammatory disease affecting the posterior segment of the eye,
often involving the retina, and is a leading cause of blindness in
developed and developing countries. It affects people of all ages,
producing swelling and destroying eye tissues, which can lead to
severe vision loss and blindness. Patients with NIPU are typically
treated with systemic steroids, which are effective, but over time
frequently lead to serious side effects, ranging from acne, weight
gain, sleep and mood disorders to hypertension and osteoporosis
that can limit effective dosing. Patients then often progress to
steroid-sparing therapy with systemic immune suppressants or
biologics, which also can have severe side effects, including an
increased risk of cancer and infection. As a result, there remains
a significant need for new therapies with improved efficacy,
tolerability, and safety profiles to manage this disease.
About Alimera Sciences, Inc.
www.alimerasciences.com
Alimera Sciences is a pharmaceutical company that specializes in
the commercialization 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 affect millions of people in our
aging populations. For more information, please visit
www.alimerasciences.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, Alimera’s expectations with
respect to sales in the Netherlands. 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, Alimera’s ability to successfully
commercialize ILUVIEN in Finland and the general acceptance by
patients and physicians of ILUVIEN to treat DME and posterior
uveitis in Finland, Alimera’s ability to launch in more Nordic
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, 2019 and Quarterly
Reports on Form 10-Q for the quarters ended March 31, 2020,
June 30, 2020, and September 30, 2020, which are on file with
the Securities and Exchange Commission (SEC) and
available on the SEC’s website at www.sec.gov.
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.
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For press inquiries: Jules Abraham for Alimera
Sciences 917-885-7378 julesa@coreir.com |
For investor inquiries: Scott Gordon for Alimera
Sciences scottg@coreir.com |
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