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.”
About ILUVIEN
www.ILUVIEN.com.
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.
www.alimerasciences.com
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: Katie Brazel for Alimera Sciences 404-317-8361 kbrazel@bellsouth.net For investor inquiries: CG Capital for Alimera Sciences 877-889-1972 investorrelations@cg.capital
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