Alimera Sciences Announces Pricing Approval For ILUVIEN® in the U.A.E.
The U.A.E. becomes the first country in the Middle East to obtain pricing approval
ATLANTA, December 17, 2018 – Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a leader in the commercialization and development of prescription ophthalmic pharmaceuticals, today announced that pricing approval had been received for ILUVIEN from the United Arab Emirates Ministry of Health & Prevention, effective January 24, 2019 through its partner MEAgate International FZLLC, headquartered in Dubai.
“Diabetes is an important disorder in our region with a high prevalence and lower levels of control by patients of their disease,” said Dr. Ahmed ElBarky, Assistant Professor of Opthalmology, Benha University, Egypt, consultant vitreoretinal surgeon, Sheikh Khalifa Medical Center in Abu Dhabi. “We are glad that ILUVIEN, which represents the latest medical introduction and innovation in the treatment of DME, is now available for our patients. ILUVIEN’s long-term effect and continuous delivery mechanism is particularly important to our patients.”
ILUVIEN is a sustained release intravitreal implant indicated for the treatment of diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. MEAgate is the ILUVIEN distributor for Bahrain, Egypt, Iraq, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, UAE, and Yemen, where an estimated 16 million people today are living with diabetes.
“The Middle East market has many patients living with diabetes and facing potential vision loss from diabetic macular edema” said Dan Myers, Alimera’s Chief Executive Officer. “With an approved price, ILUVIEN is now available in the U.A.E. enabling doctors to begin providing patients consistent treatment that controls the recurrence of edema every day.”
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant approved in the U.S. to treat diabetic macular edema 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 up to 36 months.
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. As the population of people with diabetes increases, Alimera expects the annual incidence of diagnosed DME to increase, as well.
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.
About MEAgate International FZ LCC
The management team of MEAgate are seasoned pharmaceutical and life sciences executives with over 35 years combined experience in selling pharmaceuticals and medical devices in much of the Middle East. They have developed a Middle East hub to address the needs of small to medium innovative companies and become the partner of choice that ensures highest scientific and compliant standards while managing – on behalf of the company – a network of carefully chosen country distributors. Teams are centrally selected, hired and trained, ensuring that the same high standards are applied across the region.
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 there are an estimated 16 million people living with diabetes in the countries where MEAgate is Alimera’s distributor and that a CONTINUOUS MICRODOSING delivery system will be welcomed by both retinal specialists and their patients with diabetic macular edema in the U.A.E.. 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, a difference between the actual and estimated number of diabetics in the countries covered by the agreement with MEAgate, that physicians in the Middle East will accept ILUVIEN for use with their DME patients, that ILUVIEN will be accepted by various institutions in the countries, 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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