IluvienTreatment for Diabetic Macular Edema
Alimera Sciences Announces New PDUFA Date For Iluvien
ATLANTA, April 14, 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 its recent resubmission of the New Drug Application (NDA) for Iluvien® has been acknowledged as received by the U.S. Food and Drug Administration (FDA) as a complete class 2 response to the FDA's October 2013 letter and that a Prescription Drug User Fee Act (PDUFA) goal date of September 26, 2014 has been established.
In the resubmission, Alimera responded to questions raised in the FDA's October 2013 letter and provided data from Iluvien patients and from physician experience with the applicator in the United Kingdom and Germany, where Iluvien is currently commercially available.
"We are pleased to have achieved our goal of resubmitting our NDA in the first quarter and to have a PDUFA goal date set for a decision from the FDA," said Dan Myers, Alimera's president and chief executive officer. "We look forward to the FDA's response to our NDA and hope that we will be able to make Iluvien available to patients in the United States who are suffering from chronic DME."
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.
SOURCE Alimera Sciences, Inc.
Posted: April 2014
- FDA Approves Iluvien for Diabetic Macular Edema - September 26, 2014
- pSivida Announces Resubmission of New Drug Application for Iluvien - March 27, 2014
- Alimera Sciences Receives Complete Response Letter For Iluvien - October 18, 2013
- pSivida Reports on Resubmission to FDA of NDA for Iluvien for Chronic Diabetic Macular Edema - April 2, 2013
- pSivida Reports Updates on Iluvien for Planned Resubmission to FDA and European Launch - March 22, 2013
- pSivida Corp. Reports Alimera's Intention to Resubmit Application to FDA for Iluvien in DME Using Data from Completed Trials - August 1, 2012
- pSivida Reports Receipt by Alimera Sciences of Complete Response Letter from FDA for Iluvien for DME - November 11, 2011
- pSivida Announces Resubmission of New Drug Application for Iluvien - May 13, 2011
- FDA Issues Complete Response Letter Regarding New Drug Application for Iluvien - December 26, 2010
- pSivida Announces Iluvien Receives FDA Priority Review for Treatment of Diabetic Macular Edema - August 31, 2010
- pSivida Announces Submission of NDA to FDA for an Ophthalmic Product for Diabetic Macular Edema - June 29, 2010