Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a leader in the
commercialization and development of prescription ophthalmology
treatments for the management of retinal diseases, announces that
it has expanded its relationship with Horus Pharma, one of the
Company’s current distributors of ILUVIEN® in Europe. Following the
successful launch of ILUVIEN for diabetic macular edema (DME) in
France by Horus Pharma, Alimera Sciences and Horus have agreed to
expand their relationship to introduce ILUVIEN for both DME and
non-infectious posterior uveitis (NIPU) in the Benelux countries of
Belgium, the Netherlands and Luxembourg.
Horus Pharma estimates that there are approximately 70,000
patients within the Benelux countries who may be affected by DME.
With ILUVIEN approved for both DME and NIPU in the Benelux, Horus
will undertake the process of applying for reimbursement in each
Benelux nation for each indication over the next 12-18 months.
“We have enjoyed a productive and successful relationship with
Horus Pharma, as they have obtained reimbursement for ILUVIEN in
France and are executing an impressive launch in that territory,”
said Rick Eiswirth, president and CEO of Alimera. “For those
reasons, we made the decision to expand our relationship to include
the Benelux countries where Horus also has considerable experience
and reach. We look forward to potentially adding these three more
countries to the list of anticipated ILUVIEN launches, as we
continue to execute on our global commercial expansion
strategy.”
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 percent 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)
NIPU 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.
About ILUVIEN
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is
a sustained release intravitreal implant, injected into the back of
the eye. With its CONTINUOUS MICRODOSING™ technology, ILUVIEN
is designed to release submicrogram levels of fluocinolone
acetonide, a corticosteroid, for up to 36 months to reduce the
recurrence of disease, enabling patients to maintain vision longer
with fewer injections. ILUVIEN is approved in the U.S., Canada,
Australia, 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, Czech Republic, the
Netherlands, and Luxembourg. The regulatory process is now in
the national phase in which the European member states have
finalized or are expected to finalize the label for the new
indication to meet each country’s local requirements. Timeline to
this goal varies by each country. ILUVIEN is not approved for
treatment of uveitis in the United States. See www.ILUVIEN.com for
important safety information.
About Horus Pharma S.A.S.
Founded in 2003, Horus Pharma is an independent French
laboratory specialized in ophthalmology. Horus is a European and
independent ophthalmology laboratory and has been recognized to
date as one of the main innovative European actors in corneal
reconstruction treatments, particularly in the areas of dry eye,
scarring and keratoconus. Focused on patient safety, Horus has
developed recognized expertise in the development of
preservative-free formulations and product delivery systems. For
further details, please visit www.horus-pharma.com.
About Alimera Sciences, Inc.
Alimera, founded in June 2003, is a pharmaceutical company that
specializes in the commercialization and development of
prescription ophthalmic pharmaceuticals for the management of
retinal diseases. Alimera is presently focused on diseases
affecting the back of the eye, or retina, because we believe these
diseases are not well treated with current therapies and will
affect millions of people in 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 belief that certain
patient populations will both increase and benefit from ILUVIEN,
that Horus will obtain reimbursement and successfully launch
ILUVIEN in the Benelux countries and that Alimera will continue to
execute on its strategy to grow ILUVIEN sales in existing markets
and introduce the product in new territories to maximize the value
of this differentiated therapy. Such forward-looking statements are
based on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
these expectations, and could cause actual results to differ
materially from those projected in these forward-looking
statements. Meaningful factors that could cause actual results to
differ include, but are not limited to, 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, 2018, which is on file with the Securities and Exchange
Commission and available on its website at http://www.sec.gov.
For press inquiries: Jules Abraham for Alimera
Sciences 917-885-7378 julesa@coreir.com |
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For investor inquiries: Scott Gordon for Alimera
Sciences scottg@coreir.com |
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