France's Transparency Commission Issues Positive Opinion For Reimbursement Of ILUVIEN®
ASMR level IV opinion is significant step towards commercialization in France of the first and only treatment approved for chronic diabetic macular edema
ATLANTA, July 24, 2013 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported that the Transparency Commission (Commission de la Transparence or CT) of the French National Health Authority (Haute Autorite de Sante) has issued a favorable opinion for the reimbursement and hospital listing of ILUVIEN® by the French National Health Insurance for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
In France, patients will be reimbursed for 100% of the cost of ILUVIEN under a specific program, Affection de Longue Duree, for severe chronic diseases, such as diabetes, because ILUVIEN provided a "moderate medical benefit" as defined by the Service Medical Rendu. When comparing the clinical benefit of ILUVIEN to existing therapies (Amelioration du Service Medical Rendu or ASMR), the CT rated the product at "level IV". In 2012, only 11.6 percent of all new products under CT initial review received an ASMR rating of level IV or better.
"The ILUVIEN implant features a sustained-release of the active pharmaceutical agent for up to 36 months, which is in balance with the insidious progression of macular edema due to long-term diabetes mellitus," said Pr. Gisele Soubrane, a clinical investigator for the FAME™ Study conducted by Alimera and former head of Ophthalmology at the University Hospital of Creteil, Paris XII University. "The clinical results of the trials were significant; ILUVIEN provides a new, effective mode for achieving vision improvement."
Alimera will now move forward with the next step in the process, which is to determine the price and any reimbursement conditions for ILUVIEN in France with the Comite Economique des Produits de Sante or CEPS.
"We are pleased to receive the CT's positive opinion for reimbursement of ILUVIEN," said Dan Myers, Alimera's president and chief executive officer. "We believe this opinion will help us in our discussions with the CEPS pricing committee as we work to make ILUVIEN available to those suffering from chronic DME in France."
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. ILUVIEN is injected in the back of the patient's eye where it delivers sustained sub-microgram levels of fluocinolone acetonide (FAc).
To date, six countries – Austria, the United Kingdom, Portugal, France, Spain and Germany –have granted national licenses for ILUVIEN. Currently, ILUVIEN is sold in the United Kingdom and Germany. The national license for ILUVIEN is under review by the Italian government, and the New Drug Application for ILUVIEN is under review, but has not been approved, by the United States Food and Drug Administration.
About the FAME™ Study
In the two Phase 3 pivotal clinical trials for ILUVIEN conducted by Alimera (collectively known as the FAME Study), data showed that in patients with chronic DME at month 30, after receiving the ILUVIEN implant, 38 percent of patients experienced an improvement from baseline in their best corrected visual acuity on the Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart of 15 letters or more. At the completion of the 36-month study, 34 percent had achieved the same result. This effect was highly statistically significant (p<0.001) as compared to the sham control group, which received laser and other intravitreally administered therapies.
Clinical trial data from the FAME Study was assessed for the subgroup of patients considered to have chronic DME. This assessment indicated that intraocular pressure (IOP) increases to 30 millimeters of mercury (mmHg) or greater at any time point were seen in 12.7% of these patients by month 36. By month 36, 3.6% of these patients had undergone an incisional surgical procedure to reduce elevated IOP. The incidence of cataracts among chronic patients with a natural lens in their eye at the start of the study was 84.1% at month 36, with 87.3% undergoing a cataract operation.
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 the first product to provide a therapeutic effect of up to 36 months for patients with chronic DME considered insufficiently responsive to available therapies.
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 status of pricing and reimbursement for ILUVIEN in France. 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 Alimera's ability to reach agreement with the CEPS on pricing and reimbursement for ILUVIEN, and uncertainty as to Alimera's ability to commercialize, and market acceptance of, ILUVIEN in France, 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 March 31, 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.
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