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Alimera Announces ILUVIEN® Regulatory Approval in Australia for the Treatment of Diabetic Macular Edema

Alimera Announces ILUVIEN® Regulatory Approval in Australia for the Treatment of Diabetic Macular Edema

Aug 5, 2019
Specialised Therapeutics, an Australian biopharmaceutical company and Alimera’s distribution partner, to next seek national reimbursement

ATLANTA, Aug. 05, 2019 (GLOBE NEWSWIRE) -- 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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Source: Alimera Sciences, Inc.