Alimera Obtains Marketing Authorization for ILUVIEN® in Portugal for the Treatment of Non-Infectious Posterior Uveitis
October 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
INFARMED, the governmental agency that oversees the availability of
medical products in Portugal, granted marketing authorization on
October 1, 2019 for ILUVIEN® for the prevention of relapse in
recurrent non-infectious uveitis affecting the posterior segment
(NIPU).
Alimera will market the product directly to physicians in
Portugal through its European sales organization. Alimera currently
sells ILUVIEN in Portugal for the treatment of diabetic macular
edema (DME). Once reimbursement for the new indication is granted,
Alimera will begin marketing ILUVIEN in Portugal for NIPU as
well.
“We expect the European rollout of ILUVIEN’s newly approved
indication for the treatment of NIPU to be a growth driver of our
business,” said Rick Eiswirth, president and CEO of Alimera. “We
believe that having this second indication will continue to raise
physician awareness as we have two indications in which to discuss
ILUVIEN’s ability to help patients see better, longer with fewer
injections. We look forward to providing updates on our launch of
ILUVIEN for this new indication throughout Europe and other
international territories.”
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 in Portugal
and other countries as Alimera expects, (b) whether and when
reimbursement for the new indication is granted in Portugal and
other countries where Alimera is seeking and may seek to market
ILUVIEN for NIPU, 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 June 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: 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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