Alimera’s ILUVIEN® Receives Positive NICE Recommendation for Non-Infectious Posterior Uveitis
June 20 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
the United Kingdom's National Institute for Health and Care
Excellence (NICE), in its Final Appraisal Determination for
national reimbursement, has recommended funding for ILUVIEN 190
micrograms intravitreal implant in applicator for the prevention of
relapse in recurrent non-infectious uveitis affecting the posterior
segment (NIPU).
“The NICE coverage decision for ILUVIEN is welcome news for
patients in the U.K. suffering from this disease, as reducing
relapse is a priority in the management of this condition,” said
Mr. Carlos Pavesio, Specialist Uveitis Consultant Ophthalmologist
at Moorfields Eye Hospital, London, U.K. “Preventing vision loss
associated with relapse has a huge impact on patients’ quality of
life.”
In the United Kingdom, a NICE recommendation for funding
signifies that the country’s National Health Service (NHS) will pay
for ILUVIEN prescriptions for the treatment of NIPU as part of its
offering. ILUVIEN is also funded for the treatment of diabetic
macular edema (DME) in the United Kingdom. More information on the
recommendation can be found on the NICE website at
https://www.nice.org.uk/news/article/innovative-treatment-for-inflammatory-eye-condition-recommended-for-use-on-the-nhs.
"The Birdshot Uveitis Society and our members are delighted that
NICE has approved the ILUVIEN implant for use in posterior uveitis
patients," said Annie Folkard, founding member of The Birdshot
Uveitis Society. “It is a very welcome development as this
slow-release steroid implant offers a very effective treatment
directly targeting inflammation in the eye without a lot of the
unpleasant side effects of more systemic drugs that have been
frequently used in the past.”
See www.ILUVIEN.com for important safety information.
“We continue to execute on our plans to launch ILUVIEN’s new
indication in Europe for non-infectious posterior uveitis, a
significant and, we believe, poorly-served medical need. The
positive funding recommendation from NICE facilitates patient
access in England and Wales for this second indication with funding
from the NHS,” said Rick Eiswirth, president and CEO of Alimera
Sciences. “ILUVIEN’s unique CONTINUOUS MICRODOSING™ technology
provides important sustained benefits in patients diagnosed with
both posterior uveitis and DME, and we are pleased to work with
physicians and the National Health Service in the U.K. to expand
its availability.”
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 control 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.
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 provides unique and important
sustained benefits in patients diagnosed with both posterior
uveitis and DME, that ILUVIEN will launch as planned in the U.K and
that this positive recommendation from NICE will facilitate access
to ILUVIEN for NIPU. 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: |
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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