ATLANTA, Jan. 14, 2015 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals today announced that the first unit of ILUVIEN® has been sold in Portugal for the treatment of vision impairment associated with chronic diabetic macular edema insufficiently responsive to available treatments. Portugal is the third country in which ILUVIEN is now commercially available.
The National Authority of Medicines and Health Products of Portugal (Autoridade Nacional do Medicamento e Produtos de Saude, Infarmed) granted marketing authorization to ILUVIEN, following the completion of the Decentralized Regulatory Procedure (DCP) in the European Union (EU). In July 2014, Alimera began building its commercial organization in Portugal. ILUVIEN was formally introduced to the market at the Portuguese Congress of Ophthalmology in December 2014, where it was greeted with enthusiasm.
"The first ILUVIEN sale in Portugal is significant news for the many people here with chronic DME who haven't responded well to available therapies," said Jose Cunha-Vaz, M.D., Ph.D., emeritus professor of ophthalmology, University of Coimbra, Portugal, and president of the Association for Innovation and Biomedical Research on Light and Image (AIBILI), a not-for-profit clinical research organization. "With ILUVIEN, patients may be able to resume many everyday tasks, such as driving and watching television, that were lost to DME. ILUVIEN has the potential to greatly improve their quality of life."
ILUVIEN is now approved for marketing in Austria, Belgium, Denmark, France, Germany, Ireland, Italy, the Netherlands, Norway, Portugal, Spain, Sweden, the United Kingdom and the United States, and, in addition to Portugal, is commercially available in the United Kingdom and Germany.
"With the first sale in Portugal, the commercial availability of ILUVIEN is gaining momentum, bringing us closer to our goal of helping to address the unmet need in this chronic DME patient population," said Dan Myers, Alimera's president and chief executive officer. "We are delighted that these patients, facing a severe loss of visual acuity, now have access to a new, long-term, effective treatment."
ILUVIEN (190 micrograms intravitreal implant in applicator) is a sustained release intravitreal implant used to treat patients with diabetic macular edema (DME). Each ILUVIEN implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc). ILUVIEN is injected in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound. In the two phase 3 clinical trials of ILUVIEN, collectively known as the FAME Study™, the most frequently reported adverse drug reactions included cataract development and increased ocular pressure.
In the EU, ILUVIEN is approved for vision impairment associated with chronic DME considered insufficiently responsive to available therapies. ILUVIEN is approved in the U.S. for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP).
About Alimera Sciences, Inc.
Alimera Sciences, Inc., headquartered in Alpharetta, Georgia, is a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Alimera's European operations are conducted from London by its subsidiary, Alimera Sciences Limited, which has offices in Aldershot, U.K., Berlin, Germany and Lisbon, Portugal.
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, commercialization of ILUVIEN in Portugal and the regulatory status of ILUVIEN in additional EU countries for which Alimera has applied for approval. 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, uncertainty as to Alimera's ability to commercialize, and market acceptance of, ILUVIEN in the EU, Alimera's ability to obtain marketing authorization for ILUVIEN in additional EU countries, 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, 2013 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, 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.
SOURCE Alimera Sciences, Inc.