Alimera Sciences Begins Selling ILUVIEN® in the Middle East
First DME patient in the region has received treatment
ATLANTA, Oct. 26, 2016 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a leader in research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that its subsidiary, Alimera Sciences B.V., has begun shipping ILUVIEN®, an eye implant for the treatment of diabetic macular edema (DME), to MEAgate International FZLLC, headquartered in Dubai, for Named Patient Sales in the Middle East. MEAgate is the ILUVIEN distributor for Bahrain,
Egypt, Iraq, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, UAE, and Yemen, where combined an estimated 16 million people today are living with diabetes.
Following the successful completion of a technical review, the Health Authority - Abu Dhabi (HAAD) code for ILUVIEN was published on October 11, 2016. The HAAD code allows for the reimbursement of ILUVIEN by HAAD. In addition, some large Middle East institutions are finalizing compassionate use programs in order to include ILUVIEN in their available treatment options.
The first DME patient in the region was treated with ILUVIEN under the Named Patient Sales program, an early access program whereby health authorities allow selected institutions to provide globally approved innovative medications to their patients while the products are still in the process of approval and full registration.
"Diabetes and its complications
have been listed among the top priorities of health authorities across the region," said Dream Samir, MEAgate's chief executive officer. "In several Middle-East countries, prominent ophthalmologists have confirmed that ILUVIEN will address an unmet need for a significant number of their patients with diabetes."
"We are pleased to begin providing ILUVIEN to this population," said Dan Myers, Alimera's chief executive officer. "Given the high incidence of diabetes in the region, we believe a continuous microdosing delivery system will be welcomed by both retinal specialists and their patients with diabetic macular edema."
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 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.
About Alimera Sciences, Inc.
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the research, development and commercialization 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 includes 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, 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 Middle East. 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 covered by the agreement with MEAgate on a Named Patient Sales basis on a material basis, that the governments of the countries covered by the agreement with MEAgate will allow ILUVIEN to be registered for sale and that the process of registration will not take extensive time and expense, 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, 2015 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov. Additional factors may be set forth in those sections of Alimera's Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, to be filed with the SEC in the fourth quarter of 2016. In addition to the risks described above and in Alimera's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings
with the SEC, other unknown or unpredictable factors also could affect Alimera's results. There can be no assurance that the actual results or developments anticipated by Alimera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Alimera. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely too heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). Alimera undertakes no obligation, and specifically declines
any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
For press inquiries:
for Alimera Sciences
For investor inquiries:
for Alimera Sciences
Source: Alimera Sciences, Inc.
News Provided by Acquire Media
Close window | Back to top