Alimera Announces Regulatory Approval for ILUVIEN® in Benelux Countries for The Treatment of Non-Infectious Posterior Uveiti...
December 03 2019 - 8:30AM
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
the governmental agencies that oversee the availability of medical
products in Belgium, The Netherlands and Luxembourg, collectively
known as the Benelux countries, have each granted marketing
authorization for ILUVIEN® for prevention of relapse in recurrent
non-infectious uveitis affecting the posterior segment of the eye.
The complete Benelux approval was achieved when
The Netherlands’ Medicines Evaluation Board informed Alimera of
their approval on November 6, 2019. The approval by Belgium’s
Federal Agency for Medicines and Health Products was received in
May of 2019, and Luxembourg’s Heads of Medicines Agencies provided
its confirmation of regulatory approval in late October. Alimera
announced in September that it was expanding its relationship with
French distribution partner, Horus Pharmaceuticals, who will help
the Company achieve reimbursement in all three countries, after
which it will oversee distribution throughout Benelux for the new
indication.
“We are pleased to now have the approvals for
this new indication for ILUVIEN across Benelux so that our partner,
Horus Pharmaceuticals, can now pursue reimbursement in each of
these markets for both diabetic macular edema and posterior segment
non-infectious uveitis,” said Rick Eiswirth, president and CEO of
Alimera. “Following a strong launch in France for diabetic macular
edema, we are excited to see what Horus can do with ILUVIEN in
these countries, providing us with additional markets in Europe
where we believe ILUVIEN can help physicians control the recurrence
of disease in patients who have either of these
conditions.”
See www.ILUVIEN.com for important safety
information.
About Non-Infectious Posterior
Uveitis
Posterior segment non-infectious uveitis (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. As a result,
there remains a significant need for new therapies with improved
efficacy, tolerability, and safety profiles to manage this
disease.
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
MICRODOSINGTM 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, 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.
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 these
diseases are not well treated with current therapies and will
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,
regarding Alimera’s expectation that the European roll out of
ILUVIEN’s newly approved indication for the treatment of NIPU will
be a growth driver of Alimera’s business. 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, (a) whether physicians and
patients will be receptive to using ILUVIEN for NIPU or DME in the
Benelux countries as Alimera expects, (b) whether and when
reimbursement for the indications are granted and to what amounts,
in any or all the Benelux and (c) 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 and its Quarterly Report on Form 10-Q for the quarter
ended September 30, 2019, which are on file with the
Securities and Exchange Commission and available on its website at
http://www.sec.gov.
For press inquiries: |
|
For investor inquiries: |
Jules Abraham |
|
Scott Gordon |
for Alimera Sciences |
|
for Alimera Sciences |
917-885-7378 |
|
scottg@coreir.com |
julesa@coreir.com |
|
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