U.K.'s NICE Issues Final Guidance Recommending Alimera Sciences' ILUVIEN® Published final guidance provides NHS pseudophakic patients considered insufficiently responsive to available therapies with greater access to the only sustained-release treatment for chronic diabetic macular edema
ATLANTA, Dec. 2, 2013 /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 on November 27, 2013 the United Kingdom's National Institute for Health and Care Excellence (NICE) published final guidance for ILUVIEN®, clearing the path to patient availability through the National Health Service (NHS). Patients who have a pseudophakic eye, meaning the eye has already undergone cataract surgery, will now have greater access to ILUVIEN for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
"Vision plays such a significant role in a person's overall enjoyment of life," said Winfried Amoaku, an associate professor and consultant ophthalmologist with Nottingham University Hospitals NHS Trust. "I am very pleased that pseudophakic patients with chronic DME will now have access through NHS to an effective, sustained-release therapy that could improve their sight and give them back some of the essential daily activities, such as driving and reading, that DME has taken away."
NICE requires clinical commissioning groups, NHS England and local public health authorities to comply with the recommendations in the final guidance within three months of its date of publication.
"The NICE endorsement of ILUVIEN in the United Kingdom is a significant milestone for NHS patients suffering from chronic DME," said Dan Myers, president and chief executive officer, Alimera. "These patients, insufficiently responsive to other options, now have a new treatment available to them. We hope the NHS commissioners will recognize this critical need and list ILUVIEN on hospital formularies without delay."
Alimera is now communicating closely with retinal specialists, hospital pharmacists and commissioners throughout the United Kingdom with the goal of making ILUVIEN available to suitable patients as quickly as possible.
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, 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 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, the speed with which clinical commissioning groups, NHS England and local authorities implement the recommendations contained in the published final guidance, 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.