Alimera Sciences Announces Canadian Regulatory Approval for ILUVIEN®
ATLANTA, November 26, 2018 –Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a leader in the commercialization and development of prescription ophthalmic pharmaceuticals, today announced that Health Canada has approved ILUVIEN® for the treatment of diabetic macular edema (DME). ILUVIEN is a fluocinolone acetonide sustained release intravitreal implant approved in the U.S. to treat DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Alimera signed an exclusive Canadian agreement for ILUVIEN with Knight Therapeutics, Inc. (“Knight”) in July 2015.
“We are excited that ILUVIEN has received approval by Health Canada,” said Dan Myers, CEO of Alimera. “ILUVIEN is the only treatment approved in Canada with CONTINUOUS MICRODOSING™ that can treat DME every day for up to three years with a single implant. We look forward to working with Knight to make ILUVIEN available to Canadian patients.”
“The approval of ILUVIEN is great news for Canadian DME patients, payors and healthcare providers. ILUVIEN represents a well-studied, proven effective treatment for DME patients who can benefit from CONTINUOUS MICRODOSING, without the burden of frequent injections,” said Jonathan Ross Goodman, CEO of Knight. “We are eager to work with all payors and stakeholders across Canada to make ILUVIEN available to Canadian patients.”
With the approval of ILUVIEN by Health Canada, Knight will now begin working with public and private payors to seek reimbursement for ILUVIEN, so that it can make ILUVIEN available to Canadian patients.
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant approved in the U.S. and Canada 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. Each ILUVIEN implant is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, for 36 months to treat DME consistently every day.
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% 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 Alimera Sciences, Inc.
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals. 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. Alimera’s commitment to retina specialists and their patients is manifest in Alimera’s product and development portfolio designed to treat early- and late-stage diseases. For more information, please visit www.alimerasciences.com/.
Alimera 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, the ultimate availability of ILUVIEN to Canadian patients. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, Knight’s ability to obtain reimbursement approval from the Canadian authorities and to launch ILUVIEN in Canada, as well as 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, 2017 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov.
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