Alimera Sciences Announces Approval For ILUVIEN® in Kuwait
Kuwait added to the growing number of countries with approval for ILUVIEN in the Middle East
ATLANTA, March 21, 2019 – Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a leader in the commercialization and development of prescription ophthalmic pharmaceuticals, today announced that ILUVIEN has fulfilled all requirements for registration according to the Pharmaceutical & Herbal Medicines Registration & Control Administration, Ministry of Health, Kuwait. Alimera’s partner, MEAgate International FZLLC (MEAgate), headquartered in Dubai, will be responsible for obtaining pricing and launching ILUVIEN in Kuwait.
“Prevalence of diabetes in Kuwait is approximately 30% in individuals over 40-years-old; one of the highest diabetes prevalence rates worldwide. Diabetes can affect the eye in many ways, including diabetic macular edema”, said Dr Jamal Al Kandari MD, FRCSS President of Kuwait Ophthalmology Board, Head of Ophthalmic Department in Jaber Hospital, President of (GRG) Gulf Retina Group. “The introduction of ILUVIEN with continuous microdosing delivery to Kuwait is a great step. It will help treat and control the recurrence of macular edema which will help to protect the retina and improve or maintain vision longer for many patients with fewer injections.”
ILUVIEN is a sustained release intravitreal implant that controls the recurrence of diabetic macular edema every day through its CONTINUOUS MICRODOSING™ technology, enabling patients to maintain vision longer with fewer injections. It is 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 are living with diabetes today.
“This is the second approval for ILUVIEN in the Middle East this year following approval in Lebanon last month and third overall,” said Rick Eiswirth, Alimera’s President and Chief Executive Officer. “MEAGate is eagerly awaiting pricing approval so that they can bring ILUVIEN’s unique control of edema recurrence to more patients in the Middle Eastern markets”.
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant approved in the U.S., Canada, U.A.E., Lebanon and Kuwait 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 a consistent daily dose 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. 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, that the annual incidence of diagnosed DME will increase, and that ILUVIEN will be welcomed by both retinal specialists and their patients with diabetic macular edema in Kuwait. Such forward-looking statements are based on current expectations and information 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, the willingness of physicians in the Middle East to accept ILUVIEN for use with their DME patients, and that ILUVIEN will be accepted by various institutions in the countries Alimera has identified as opportunities, 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, 2018 and Quarterly Report on Form 10-Q for the quarter ended December 31, 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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SOURCE: Alimera Sciences, Inc.