Alimera Sciences Announces New 36-Month Analysis That Shows ILUVIEN® Slows Diabetic Retinopathy Progression
Data presented as Late Breaking Development during Retina Subspecialty Day at AAO 2015
Nov 16, 2015, 07:30 ET
ATLANTA, Nov. 16, 2015 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that a new analysis of patients from the FAME™ Study demonstrated a significant slowing of the progression of diabetic retinopathy (DR) in patients with diabetic macular edema (DME) treated with ILUVIEN®.
"Analysis of Diabetic Retinopathy Progression in Patients Treated with 0.2 micrograms/day Fluocinolone Acetonide Over 36 Months" was presented by Charles C. Wykoff, M.D., Ph.D., Retina Consultants of Houston, as a Late Breaking Development during the Retina Subspecialty Day at the American Academy of Ophthalmology Annual Meeting 2015 in Las Vegas. In this analysis, continuous, low dose therapy with ILUVIEN (0.2 micrograms/day Fluocinolone Acetonide) in the FAME Study was evaluated to determine its effect on progression to proliferative diabetic retinopathy (PDR), and the worsening of PDR, in DME patients. Along with the development of DME, these represent the most clinically significant measures of worsening of DR.
At month 36, statistically significantly fewer ILUVIEN-treated eyes experienced progression of PDR (17%) versus sham-treated eyes (31%) (p<0.001). Progression of PDR in the FAME Study was determined based on fundus photographs that were graded by a masked, certified reading center, and by the incidence of the use of pan-retinal photocoagulation and the incidence of vitrectomy to treat PDR.
"The data demonstrate an important clinical benefit from continuous, low-dose corticosteroid therapy provided by ILUVIEN," said Dr. Wykoff. "From the physician's perspective, being able to treat diabetic retinopathy in patients with DME with one injection is exciting. This important development demonstrates the therapeutic benefit of the continuous, multi-year treatment delivered by ILUVIEN."
"We believe these results demonstrate the potential for ILUVIEN to significantly slow the progression of diabetic retinopathy," said Dan Myers, Alimera president and chief executive officer. "This type of disease modifying effect has only been reported for anti-VEGF therapy when administered monthly over a multi-year period. Achieving this effect with ILUVIEN represents a significant benefit which we believe will extend to actual clinical practice and to patients."
The FAME Study consisted of two three-year, Phase 3 pivotal clinical trials, Trial A and Trial B, to assess the safety and efficacy of ILUVIEN in the treatment of DME. Statistically significant differences between ILUVIEN-treated eyes and sham-treated eyes were seen in both progression to PDR and the time to progression to PDR in both Trial A and Trial B. Patients in the FAME Study received a mean of 1.3 ILUVIEN injections.
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 therapeutic benefit of ILUVIEN in the treatment of diabetic retinopathy, the potential for ILUVIEN to slow the progression of diabetic retinopathy, and the benefit to clinical practices and patients of using ILUVIEN. 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 clinical results could differ from the results of the FAME Study and uncertainty as to physician acceptance of the results of this new analysis of patients, 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 September 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.
SOURCE Alimera Sciences, Inc.
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