ATLANTA, April 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 marketing authorization has been granted by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Poland to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
The Polish approval marks the 17th and final country authorization to be granted through the European Repeat-Use application procedure. ILUVIEN is now approved for marketing in the following European countries: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden and the United Kingdom. In Europe, ILUVIEN is commercially available in the United Kingdom, Germany and Portugal.
"With Poland, we have secured marketing approval from all 17 of the European countries in which we filed. We are excited that ILUVIEN, the only long-term, multiyear sustained release treatment for chronic DME, has broad approval across Europe," said Dan Myers, Alimera's president and chief executive officer. "We are continuing our efforts to make this effective treatment accessible to additional DME patients for whom ILUVIEN is indicated."
About the Mutual Recognition Procedure
In the Mutual Recognition Procedure (MRP), a medicine is first authorized in one EU 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.
In addition, ILUVIEN was approved by the U.S. Food and Drug Administration in September 2014 and became commercially available throughout the U.S. in February 2015.
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 delivers sustained multiyear 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.
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 potential commercial availability of ILUVIEN in Poland and other European countries. 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, 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, 2014, which is 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 forth in those sections of Alimera's Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, 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.