ATLANTA, March 17, 2021 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmology treatments for the management of retinal diseases, announces continued execution on its geographic expansion strategy with publication of ILUVIEN pricing in Denmark and Luxembourg. In addition, the Company received approval for reimbursement for the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) from the three largest private health insurers in Ireland.
“Alimera continues to make incremental progress on our global expansion strategy, regularly receiving approval for distribution and reimbursement by the regulatory authorities in new countries, despite the fact that we continue to feel the effects of the global pandemic of COVID-19,” stated Rick Eiswirth, Alimera’s President and CEO. “While the health status may vary country by country, presenting challenges to those doctors trying to prescribe ILUVIEN to their patients, we continue to receive the consistent message from both the healthcare professionals and the regulatory authorities reviewing our applications that ILUVIEN has a measurable impact on patients.”
In March, the price of ILUVIEN was made public in Denmark where ILUVIEN is approved for both the DME and NIU-PS indications. Earlier in the quarter, Luxembourg’s Ministry of Health approved ILUVIEN for reimbursement for DME. In Ireland, the three largest private insurers, which together represent approximately 50% of covered lives in the country, also recently approved ILUVIEN for reimbursement in private hospitals under its health plans. The Company is still waiting for the public health system to grant reimbursement.
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant that is injected into the back of the eye. With its CONTINUOUS MICRODOSING™ technology, ILUVIEN is designed to release sub-microgram levels of fluocinolone acetonide, a corticosteroid, for 36 months, to reduce the recurrence of disease and number of treatments required, enabling patients to maintain vision longer with fewer injections. ILUVIEN is approved in the U.S., Canada, Kuwait, Lebanon and the U.A.E 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. In 17 European countries, ILUVIEN is indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. In March 2019, ILUVIEN received approval in the 17 countries under the Mutual Recognition Procedure for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye. The 17 European countries include the U.K., Germany, France, Italy, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden, Poland, Czechia, the Netherlands, and Luxembourg. The non-infectious posterior uveitis indication for ILUVIEN was launched in Germany and the U.K. in 3Q 2019. ILUVIEN is not approved for treatment of uveitis in the United States.
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 Sciences 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 affect millions of people in our aging populations. For more information, please visit www.alimerasciences.com.
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 expectations with respect to continued geographic expansion. 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, Alimera’s ability to successfully commercialize ILUVIEN in Denmark, Luxembourg and Ireland and the general acceptance by patients and physicians of ILUVIEN to treat NIU-PS in Denmark, Luxembourg and Ireland, as well as other factors discussed in the “Summary of Principal Risk Factors,” “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, 2020 which is on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov.
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.
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