-- SMC advice follows positive NICE final guidance issued in November 2013
ATLANTA, Feb. 10, 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 the Scottish Medicines Consortium (SMC), after completing its assessment and review of a simple patient access scheme, has accepted ILUVIEN® for restricted use within the National Health Service (NHS) Scotland.
The advice issued by the SMC provides NHS Scotland patients considered insufficiently responsive to available therapies with access to ILUVIEN, the only sustained-release treatment for chronic diabetic macular edema (DME). The advice is restricted to those who have a pseudophakic eye, meaning the eye has already undergone cataract surgery. In addition, retreatment with ILUVIEN is predicated on a positive response to, and subsequent need for the product.
"The SMC acceptance of ILUVIEN is wonderful news for DME patients in Scotland," said Dr. William Wykes, consultant ophthalmologist at NHS Southern General Hospital, and lead clinician, diabetic retinopathy, NHS Greater Glasgow and Clyde, the largest health board in Scotland. "Vision is so important to a person's overall quality of life, and now pseudophakic patients with chronic DME in Scotland will have access through NHS Scotland to an effective, sustained-release therapy that could improve their sight."
"The favorable assessment and acceptance of ILUVIEN by the SMC is a major step forward for NHS Scotland patients suffering from chronic DME," said Dan Myers, president and chief executive officer, Alimera. "Patients of NHS Scotland, who are insufficiently responsive to other treatment options, now have access to a product that can provide a therapeutic benefit to them for up to 36 months."
ILUVIEN (190 micrograms intravitreal implant in applicator) is a sustained release intravitreal implant used to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. 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 FAME™ Study, a phase III clinical study of ILUVIEN, the most frequently reported adverse drug reactions included cataract development and increased ocular pressure. ILUVIEN has not been approved for sale in the United States.
About Alimera Sciences, Inc.
Alimera Sciences, Inc., headquartered in Alpharetta, Georgia, is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Alimera's European operations are conducted from London by its wholly-owned 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, Alimera's commercial plans for ILUVIEN in Scotland. 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, the commercial demand and availability of ILUVIEN in Scotland, 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, 2012 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, which are 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.