Alimera Sciences Announces the Reimbursement of ILUVIEN® in Spain
Spain becomes the seventh country in Europe to grant reimbursement for ILUVIEN
ATLANTA, May 31, 2018 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a leader in the commercialization and development of prescription ophthalmic pharmaceuticals, today announced that its subsidiary, Alimera Sciences Limited, received a positive resolution for the pricing and reimbursement approval for ILUVIEN® from the Spanish Ministry of Health on May 11, 2018. This means that in Spain, ILUVIEN should be fully reimbursed for use in line with the European label indication with a restriction to patients with an artificial lens implanted. This approval was sought and secured by Alimera's distributor partner in Spain, Brill Pharma (Brill). ILUVIEN is a sustained release intravitreal implant indicated for the treatment of vision impairment associated with chronic diabetic macular edema (DME) in Spain.
"The diabetic patient with retinopathy now has a new 'therapeutic weapon' for the treatment of its main complication: macular edema," said Dr. Jose Ruiz Moreno, president of the SERV (Sociedad Espanola de Retina y Vitreo) – Spanish Society of Retina and Vitreous. "This is great news, for the patient and for the ophthalmologist."
"Spain is a well-established intraocular steroid market and we believe the availability of an innovative product to uniquely treat the disease consistently every day to reduce the recurrence of edema will receive a warm welcome from retinal specialists." said Dan Myers, Alimera's chief executive officer, "The approval provides a clear path to a new revenue stream with Spain becoming the fourth of the five largest European countries to grant reimbursement for ILUVIEN."
ILUVIEN will be distributed throughout Spain by Brill. Under the terms of the five-year agreement signed in March 2017, Brill is handling all promotion, marketing and commercial activities for ILUVIEN, and was responsible for the successful pursuit of this approval.
"ILUVIEN meets an unmet clinical need in the treatment of DME since it frees the patient from the burden of frequent injections," said Dr. Jordi Martinez Rotllan, chief executive officer of Brill Pharma. "With continuous microdosing, ILUVIEN delivers treatment every day for up to 36 months, and reduces the recurrence of the disease. This truly is unique and an advancement for the treatment of patients in Spain."
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant indicated in the EU to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each ILUVIEN implant with its continuous microdosing is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, for 36 months, enabling the physician to treat this persistent disease consistently every day.
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 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 portfolio. For more information, please visit www.alimerasciences.com.
About Brill Pharma S. L.
Brill Pharma, the Spanish subsidiary of Bristol Laboratories U.K., is based in Barcelona, Spain and was established in September 2012. It markets innovative products in ophthalmology, is already ranked fourth in this specific segment of the Spanish pharma market and was recently recognized as the fastest growing Spanish pharma company in its segment. The company employs more than 60 medical representatives covering Spain. For further details, please visit www.brillpharma.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 regarding the receipt of revenue from the sale of ILUVIEN by its distributor in Spain. 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, the sufficiency of insurance reimbursement by the Spanish authorities, Brill's ability to timely launch ILUVIEN in 2018 in Spain in a meaningful way and to provide adequate promotion, marketing and commercial support for ILUVIEN, and the degree to which physicians and hospitals in Spain accept ILUVIEN for administration to their DME patients, 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 March 31, 2018, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov. 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.
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SOURCE: Alimera Sciences, Inc.