ATLANTA, Nov. 12, 2014 /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 Belgian Federal Agency for Medicines and Health Products (FAMHP) has granted marketing authorization to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
Approval in Belgium marks the fourth European approval through the Repeat-Use application procedure and the 12th approval worldwide, including the recent U.S. approval 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). To date, ILUVIEN is now approved for marketing in Austria, Belgium, Denmark, France, Germany, Italy, Norway, Portugal, Spain, Sweden, the United Kingdom and the United States, and is commercially available in the United Kingdom and Germany. ILUVIEN is pending approval in an additional six European Union (E.U.) countries included in the Repeat-Use application procedure. These countries are the Czech Republic, Finland, Ireland, Luxembourg, the Netherlands and Poland.
"With the marketing approval of ILUVIEN in Belgium, more patients in Europe are closer to gaining access to the only long-term, multi-year sustained release treatment for DME, and the only treatment indicated for the chronic form of the disease," said Dan Myers, Alimera's president and chief executive officer. "As recent studies have underscored the role of inflammation in DME, the approval of our continuous three-year, anti-inflammatory intravitreal injection will bring an important treatment option for many chronic DME patients."
About the Mutual Recognition Procedure
In the Mutual Recognition Procedure (MRP), a medicine is first authorized in one E.U. Member State, in accordance with the national procedures of that country. A Marketing Authorization Holder (MAH) can use the MRP for the same authorization more than once after completion of a first decentralized procedure (DCP) and obtain marketing authorization in other Member States. According to the European Commission Directive guidance, this is known as Repeat-Use, and is a procedure where those Member States, not involved in the first DCP, agree to recognize the validity of the original, national marketing authorization.
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.
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). In the E.U., ILUVIEN is approved for vision impairment associated with chronic DME considered insufficiently responsive to available therapies.
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.
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, the regulatory status and potential commercialization of ILUVIEN in Belgium and the six additional E.U. 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 June 30, 2014, 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 also be set forth in those sections of Alimera's Quarterly Report on Form 10-Q for the quarter ended September 30, 2014 to be filed with the SEC. 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.