Alimera Sciences Announces Resubmission Of ILUVIEN® New Drug Application To FDA
Published: Mar 27, 2014
ATLANTA, March 27, 2014 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it has resubmitted its New Drug Application for ILUVIEN® to the U.S. Food and Drug Administration (FDA). At this time, Alimera awaits the FDA's acceptance of the resubmission and a Prescription Drug User Fee Act (PDUFA) date. Alimera intends to provide that information when it becomes available.
In the resubmission, Alimera responded to questions raised in the FDA's October 2013 complete response letter and provided a safety update, which included commercial experience with ILUVIEN in Europe.
"We are pleased to resubmit ILUVIEN for approval in the United States," said Dan Myers, Alimera's president and chief executive officer. "We look forward to an acknowledgment from the FDA that the response is complete and that a PDUFA date has been confirmed."
ILUVIEN (190 micrograms fluocinolone acetonide intravitreal implant in applicator) is a sustained release intravitreal implant that 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 Alimera's FAME Study, the most frequently reported adverse drug reactions included cataract operation, cataract and increased ocular pressure.
ILUVIEN has received marketing authorizations in Austria, the United Kingdom, Portugal, France, Germany and Spain and is commercially available in the United Kingdom and Germany. ILUVIEN is indicated for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. ILUVIEN has not been approved for sale in the United States.
About Alimera Sciences, Inc.
Alimera Sciences, Inc., based in Alpharetta, Georgia, is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals.
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 of ILUVIEN in the United States. 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, delay in or failure to obtain FDA approval of ILUVIEN, 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, which is 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.
For press inquiries:
Katie Brazel, FleishmanHillard
for Alimera Sciences
For investor inquiries:
John Mills, ICR
for Alimera Sciences
SOURCE Alimera Sciences, Inc.
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