Alimera Announces ILUVIEN® Regulatory Approval in Australia for the Treatment of Diabetic Macular Edema
August 05 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 today
that the Australian Therapeutic Goods Administration (TGA), the
division of the Australian Department of Health that oversees the
availability of medical products, has approved ILUVIEN® (190
micrograms intravitreal implant in applicator) for the treatment of
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.
ILUVIEN will be commercialized throughout Australia by
Specialised Therapeutics under exclusive license from Alimera
Sciences.
“We are delighted to make this important new therapy available
to Australian patients affected by DME following the successful
navigation of a complex regulatory process,” said Carlo Montagner,
CEO of Specialised Therapeutics. “Our commercial teams will now
work to ensure that all appropriate patients will have access to
this therapy at the earliest opportunity as we now seek ILUVIEN
reimbursement through the Australian Pharmaceutical Benefits
Scheme.”
“With this approval, we continue to execute on our strategy to
grow ILUVIEN sales in existing markets and introduce the product in
new territories to maximize the value of this differentiated
therapy,” said Rick Eiswirth, president and CEO of Alimera. “We are
proud to collaborate with Specialised Therapeutics and to make
ILUVIEN available to patients in Australia who are suffering from
DME and would like the opportunity to see better, longer with fewer
injections.”
See www.ILUVIEN.com for important safety information.
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 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, 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.
About Specialised Therapeutics Specialised
Therapeutics is an international biopharmaceutical company
established to commercialize new therapies and technologies to
patients throughout Australia as well as in New Zealand and South
East Asia. ST and its regional affiliates collaborate with leading
global pharmaceutical and diagnostic companies to bring novel,
innovative and life-changing healthcare solutions to patients
affected by a range of diseases. Its mission is to provide
therapies where there is an unmet need. The company’s broad
therapeutic portfolio currently includes novel agents in oncology,
hematology, neurology, ophthalmology and supportive care.
Additional information can be found at www.stbiopharma.com.
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
physicians and patients in Australia will be receptive to ILUVIEN
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 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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