U.K.'s National Institute for Health and Clinical Excellence Accepts Alimera Sciences' ILUVIEN® Subgroup Data for Review Additional data focuses on patients with chronic diabetic macular edema who have already undergone cataract surgery
ATLANTA, Sept. 5, 2012 /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 the United Kingdom's National Institute for Health and Clinical Excellence (NICE) has accepted for consideration additional data in the form of an appendix to Alimera's comments on the preliminary Appraisal Consultation Document (ACD) previously issued by NICE for the ILUVIEN® Single Technology Appraisal (STA).
NICE's Appraisal Committee, which issued the preliminary ACD in August, is currently evaluating the cost-effectiveness of ILUVIEN for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
On September 4, 2012, NICE informed Alimera that the Appraisal Committee required adequate time to thoroughly review the additional data. Therefore, the Second Appraisal Committee meeting, previously scheduled for September 11, 2012, has been rescheduled for October 11, 2012. According to NICE's Guide to the STA, new data is only accepted if it is likely to affect the provisional recommendations in the ACD.
As Alimera was drafting its response to the ACD, the company determined that ILUVIEN was more cost-effective in a pseudophakic patient subgroup of Alimera's FAME™ Study, providing additional support to its ACD response submission. As a result of diabetes, age or previous DME treatments, each patient in this subgroup had an artificial lens in his or her eye at the start of the study. Patients with an artificial lens cannot further develop a cataract in the treated eye due to their exposure to the corticosteroid delivered via ILUVIEN. These patients will not experience the transient reduction in visual acuity as the result of cataract development that occurred in some patients during the first two years of the FAME Study, nor will they incur the cost associated with cataract surgery.
"We remain hopeful that NICE will recognize ILUVIEN as a cost-effective therapy for all patients diagnosed with chronic DME who are insufficiently responsive to currently available therapies. The NICE Appraisal Committee's acceptance of our appendix submission presents the possibility of earlier patient access for patients with limited therapeutic options within the United Kingdom," said Dan Myers, president and chief executive officer, Alimera Sciences. "We look forward to NICE's review of this subgroup data, and we will continue to work closely with NICE in an effort to make this valuable treatment option available to patients in the United Kingdom as soon as possible."
ILUVIEN (190 micrograms fluocinolone acetonide intravitreal implant in applicator) is a sustained release intravitreal implant used to treat chronic 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 inserted 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 FAME Study, the most frequently reported adverse drug reactions included cataract operation, cataract and increased ocular pressure.
In July 2010, Alimera submitted a Marketing Authorization Application (MAA) to seven European countries via the Decentralized Procedure (DCP) with the Medicines and Healthcare products Regulatory Agency of the U.K. (MHRA) serving as the Reference Member State (RMS). The MAA included data from two Phase 3 pivotal clinical trials (collectively known as the FAME Study) for ILUVIEN conducted by Alimera. The trials involved 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of ILUVIEN for the treatment of DME. At the end of the DCP, a consensus was reached by the RMS and the other six countries that the MAA for ILUVIEN is approvable. To date, five of the seven countries, Austria, the United Kingdom, Portugal, France and Germany have granted national licenses for ILUVIEN. ILUVIEN has not been approved by the United States Food and Drug Administration.
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. Presently Alimera is focused on diseases affecting the back of the eye, or retina. Its primary product, ILUVIEN, is an intravitreal implant containing fluocinolone acetonide (FAc), a non-proprietary corticosteroid with demonstrated efficacy in the treatment of ocular disease.
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, Alimera's commercial plans for ILUVIEN in the United Kingdom. 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, NICE's decision regarding the ILUVIEN STA, uncertainty as to Alimera's ability to commercialize (alone or with others), and market acceptance of, ILUVIEN in Germany, the United Kingdom and France, and 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, 2011 and Quarterly Report on Form 10-Q for the quarters ended March 31, 2012 and June 30, 2012, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov. 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.