Alimera Sciences Launches ILUVIEN® in Germany For Non-Infectious Uveitis Indication
September 03 2019 - 8:00AM
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 will immediately commence the launch of ILUVIEN in Germany for
the prevention of relapse in recurrent non-infectious uveitis
affecting the posterior segment of the eye (NIPU). Following the
European Union’s Mutual Recognition Procedure in March 2019,
Germany is the second country in Europe in which ILUVIEN is now
commercially available to be prescribed to patients suffering from
NIPU, a disease with no sustained treatment options. In June 2019,
Alimera announced a positive recommendation by the National
Institute for Health and Care Excellence (NICE), facilitating
launch of the NIPU indication in the United Kingdom.
“New therapeutics for non-infectious uveitis are urgently
needed, as there are few options available while potential for
vision loss is very real. The availability of ILUVIEN now provides
a long-acting, intravitreal treatment option for our patients that
closes a gap in the care needs of this chronic disease,” said
Professor Dr. med. Carsten Heinz FEBO, Augenzentrum am St.
Franziskus-Hospital, Munster, Germany. “ILUVIEN has a
well-established efficacy and safety profile for the continuous
treatment of diabetic macular edema and now patients with
non-infectious uveitis affecting the posterior segment can expect
similar benefits and - due to the local application – no occurrence
of the unwanted systemic effects of long-term corticosteroid
therapy.”
Launch of the NIPU indication follows the establishment of
national pricing and receipt of the required regulatory approval by
the Federal Institute for Drugs and Medical Devices
(Bundesinstitut für Arzneimittel und Medizinprodukte or BfArM), the
medical regulatory authority in Germany. Germany is
Alimera’s largest direct market in Europe based on current sales
for ILUVIEN’s diabetic macular edema (DME) indication, and it is
estimated that the number of patients diagnosed with NIPU is
approximately 15-20% of the DME patient population.
“The launch in Germany represents our second country rollout for
ILUVIEN’s expanded European indication for uveitis, a retinal
disease that anti-VEGF drugs do not treat,” said Rick Eiswirth,
president and CEO of Alimera Sciences. “We continue to receive
encouraging feedback from physicians regarding ILUVIEN’s unique
CONTINUOUS MICRODOSING™ technology, with its ability to reduce the
recurrence of disease in patients diagnosed with either
non-infectious posterior uveitis or DME.”
About Non-Infectious Posterior Uveitis
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 non-infectious
posterior uveitis (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 MICRODOSING technology, ILUVIEN is
designed to release submicrogram levels of fluocinolone acetonide,
a corticosteroid, for 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.
See www.ILUVIEN.com for important safety information.
About Alimera Sciences, Inc.
www.alimerasciences.com
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, Alimera’s belief that
ILUVIEN’s CONTINUOUS MICRODOSING technology has the ability to
reduce the recurrence of disease in patients diagnosed with
non-infectious posterior uveitis or DME, and that ILUVIEN will
launch as planned in Germany. Such forward-looking statements are
based on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
either of them, and could cause actual results to differ materially
from those projected in its 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 Abrahamfor Alimera
Sciences 917-885-7378julesa@coreir.com |
For investor inquiries:Scott Gordonfor Alimera
Sciencesscottg@coreir.com |
Alimera Sciences (NASDAQ:ALIM)
Historical Stock Chart
From Aug 2024 to Sep 2024
Alimera Sciences (NASDAQ:ALIM)
Historical Stock Chart
From Sep 2023 to Sep 2024