Alimera Sciences Limited Announces ILUVIEN® Study Results Presented At 15th Euretina Congress
Interim six-month data confirms ILUVIEN was well tolerated and effective in reducing retinal thickness and increasing best corrected visual acuity
ATLANTA and LONDON, Sept. 24, 2015 /PRNewswire/ -- Alimera Sciences, Inc., (NASDAQ: ALIM) (Alimera), a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced that Alimera Sciences Limited, its European subsidiary based in London, revealed interim six-month data on ILUVIEN® (Fluocinolone Acetonide 190 micrograms intravitreal implant in applicator) from the ongoing study referred to as RESPOND, a non-Randomised, open-label, multicenter phase 4 pilot study on the Effect and Safety of ILUVIEN® Fluocinolone Acetonide in chronic diabetic macular edema Patients cOnsidered iNsufficiently responsive to available therapies with or without intravitreal corticosteroiD therapy. The study is focused on the efficacy and safety of ILUVIEN, the first sustained release pharmaceutical product for the treatment of vision impairment associated with chronic diabetic macular edema (DME), considered insufficiently responsive to available therapies. The study data were presented at the 15th EURETINA Congress in Nice, France on September 17, 2015.
RESPOND is sponsored by AIBILI (Association for Innovation and Biomedical Research on Light and Image), funded by Alimera Sciences Limited, and is being conducted at four sites in Portugal. RESPOND enrolled 12 patients with chronic DME that did not respond sufficiently to previous treatments, laser and/or anti-vascular endothelial growth factor agents with or without corticosteroids. Each received a single injection of ILUVIEN (190 micrograms intravitreal implant in applicator) and will be followed for 12 months to gauge the effectiveness of the drug to improve visual acuity and reduce retinal thickness. The study will also closely monitor safety variables, such as a rise in intraocular pressure (IOP) and cataract progression.
The interim 6-month results showed that ILUVIEN was well tolerated and effective in reducing retinal thickness and increasing visual acuity. Of 11 patients completing their six-month visit, nine (82%) maintained or improved their Best Corrected Visual Acuity (BCVA) from baseline and 10 patients (91%) experienced a decrease in central subfield thickness (CST). The 11 patients with six months of follow up gained an average of 7.1 letters in BCVA from baseline and experienced an average decrease in CST of 300.6 microns from baseline.
"From clinical practice, we now understand that ILUVIEN provides a confirmed, sustained and fast efficacy with less safety concerns than initially presumed," said Dr. Joao Figueira, RESPOND coordinating investigator and principal investigator for the Center for Clinical Trials at AIBILI in Portugal.
"It is gratifying that ILUVIEN continues to show excellent results both in phase 4 clinical studies and in European physician's practices in patients who were considered insufficiently responsive to other treatments," said Dan Myers, president and chief executive officer, Alimera Sciences. "These early results are consistent with our belief that ILUVIEN would perform as well in clinical practice as was experienced in the FAME Study. We are pleased to work with the AIBILI team as they continue to follow the RESPOND patients, and we look forward to the 12-month results."
About ILUVIEN®
ILUVIEN Fluocinolone Acetonide (190 micrograms intravitreal implant in applicator) is a sustained release intravitreal implant indicated in the European Union for the treatment of vision impairment associated with chronic diabetic macular edema, considered insufficiently responsive to available therapies. Each ILUVIEN implant provides 36 months of sustained treatment achievable with one injection by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc). The ILUVIEN implant is administered via a simple perpendicular intravitreal injection1. The applicator employs a 25-gauge needle, which produces a small self-sealing wound in the pars plana. In the two randomised, multicentre, double-masked, parallel phase 3 clinical trials of ILUVIEN, collectively known as the FAME™ Study, the most frequently reported adverse drug reactions included cataract development and increased ocular pressure.
About Diabetic Macular Edema (DME)
DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage associated with diabetic retinopathy results in swelling of the macula, the condition is called DME. The onset of DME is painless and may go unreported by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period approximately 19% of people with diabetes included in the study were diagnosed with DME. All people with type 1 or type 2 diabetes are at risk of developing DME. As the population of people with diabetes increases, Alimera expects the annual incidence of diagnosed DME to increase, as well.
About Alimera Sciences, Inc.
Alimera Sciences, Inc., headquartered in Alpharetta, Georgia, is a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Alimera's European operations are conducted from London by its 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, the efficacy and safety of ILUVIEN® and assumptions regarding the prevalence of DME. 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 possibility that the final results of the RESPOND study at 12 months differ materially from the interim results reported at six months and uncertainty as to physician acceptance of the RESPOND study data, 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, 2014 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2015 , 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.
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