October 12, 2011

Alimera Sciences Highlights 36-Month FAME™ Study Data on ILUVIEN® at AAO 2011 Annual Meeting

ILUVIEN Results for DME Patients to be Discussed in Presentations and Poster, at Retina Subspecialty Day and on Main Exhibit Floor

ATLANTA, Oct. 12, 2011 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc., (Nasdaq:ALIM) ("Alimera"), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that 36-month data from its Phase 3 FAME™ study of ILUVIEN® will be presented at the annual meeting of the American Academy of Ophthalmology (AAO), to be held October 22 through October 25, 2011 at the Orange County Convention Center in Orlando, Florida. ILUVIEN is Alimera's investigational intravitreal insert being studied for the treatment of diabetic macular edema (DME).

During the 2011 Retina Subspecialty Day program, to be held October 21 and October 22, Peter A. Campochiaro, M.D., The Wilmer Eye Institute at Johns Hopkins, will present "ILUVIEN for DME" during the RET17 Section XII: Diabetes session at 2:25 p.m. on Saturday, October 22 in the Valencia Room W415abc.

On Sunday, October 23, David J. Browning, M.D., Ph.D., Charlotte Eye, Ear, Nose & Throat Associates, P.A., will be on-site, between 2:00 p.m. and 3:00 p.m., to discuss his poster entitled, "Fluocinolone Acetonide Intravitreal Inserts Have a Low Risk of IOP Increase Requiring Surgery or Increase in Cup-to-Disc Ratio in Diabetic Macular Edema." The poster, located in Hall A1, will be available for review throughout the entire annual meeting.

David M. Brown, M.D., FACS, The Methodist Hospital, Houston, Texas, is slated to present in the retina paper session at 11:51 a.m. on Monday, October 24 in room W414cd. The data in Dr. Brown's presentation, titled "A Single 0.2 micrograms per day dose Fluocinolone Acetonide Injectable Insert Provides Improved Visual Acuity for Up to 36 Months in Diabetic Macular Edema," were derived from observed cases in the FAME study, which indicated that at 36 months, 38.9 percent of patients with chronic DME experienced an improvement from baseline in their best corrected visual acuity (BCVA) on the early treatment diabetic retinopathy study (ETDRS) eye chart of 15 letters or more.

"With the incidence of DME on the rise, it is critical for retinal specialists to become aware of new potential treatment options for this disease, especially for patients with chronic persistent DME," said Dr. Brown. "The ILUVIEN data is particularly exciting as it demonstrates that a single insert can provide rapid and sustained improvement in visual acuity for up to 36 months."

Alimera scientific personnel will be present on Friday, October 21 at subspecialty booth #61 in the West Building, Level 2, Hall C, and from October 22 through October 25 at booth #2536 on the main exhibit floor in the West Building, Level 2.

"We are looking forward to having such a strong presence at AAO 2011, and to sharing additional analyses of the ILUVIEN FAME study's 36-month data," said Dan Myers, president and CEO of Alimera. "At this forum of experts in ophthalmology, we are pleased to showcase ILUVIEN as a potential treatment for DME."

In May 2011, Alimera resubmitted the ILUVIEN New Drug Application (NDA) to the U.S. Food and Drug Administration and expects a communication from the agency regarding the NDA by November 12, 2011.

About the FAME Study

Alimera conducted two 36-month, Phase 3 pivotal clinical trials (collectively known as the FAME Study) for ILUVIEN involving 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of ILUVIEN with two doses of the corticosteroid fluocinolone acetonide (FAc), a high and low dose, for the treatment of DME. The primary efficacy endpoint for the FAME Study was the difference in the percentage of patients whose BCVA improved by 15 or more letters from baseline on the ETDRS eye chart at month 24 between the treatment and control groups. The study concluded in September 2010 with the final patient visit at the three-year data point.

In February 2011, Alimera presented positive results from the full patient population. At month 36, the percentages of subjects with demonstrated improvement in BCVA of 15 letters or more from baseline were 28.4% and 29.0% for Trial A and Trial B respectively. Statistical significance was seen in both trials as late as month 33 with Trial A at 28.4% (p=0.042) and Trial B at 29.6% (p=0.046).

The FAME study results included additional data from a subgroup of study patients that was identifiable prior to administration of ILUVIEN. This subgroup reflected the duration of DME at baseline and across all patients randomized, with a median duration of DME at baseline of three years.

Of the patients diagnosed with DME for three years or more who were treated with ILUVIEN, 31.8% (p=0.010) in Trial A and 36.4% (p=0.004) in Trial B experienced BCVA improvement of 15 letters or more from baseline at 36 months. Of the patients in the subgroup who received the control treatment, 13.6% in Trial A and 13.2% in Trial B experienced BCVA improvement of 15 letters or more from baseline at 36 months. Consistent with the full patient population, approximately 75% of the patients who were treated with ILUVIEN received only one ILUVIEN insert over the 36 month study. No statistical significance in BCVA improvement was found in the subgroup of patients with less than three years duration of DME.

Data for the subgroup was gathered from 536 patients who had been diagnosed with DME for three years or more and 416 patients who had been diagnosed with DME for less than three years.

About FAME Safety

Safety was assessed among those patients treated with ILUVIEN who were in the subgroup of patients with DME for three years or more and were considered to have chronic DME. Intraocular pressure (IOP) increases to 30 millimeters of mercury (mmHg) or greater at any time point were seen in 14.8% of these patients by month 36, compared to 18.3% in the full ILUVIEN treated patient population. By month 36, 5.3% of these patients had undergone an incisional surgical procedure to reduce elevated IOP, compared to 4.8% in the full patient population. The incidence of cataracts among patients with a natural lens in their eye at the start of the study was 86% at month 36, with 85% undergoing a cataract operation, compared to 80% and 74.9%, respectively, in the full patient population.

About 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 of diabetic retinopathy causes swelling in the macula, the condition has progressed to DME. The onset of DME is painless and may go undetected 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 percent of people with diabetes studied were diagnosed with DME. As the population of people with diabetes increases, Alimera expects the annual incidence of diagnosed DME to increase, as well.


ILUVIEN is an investigational, extended release intravitreal insert that Alimera is developing for the treatment of DME. Each ILUVIEN insert is designed to provide a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc). ILUVIEN is inserted in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The insertion device employs a 25-gauge needle, which allows for a self-sealing wound.

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 advanced product candidate, ILUVIEN, is an intravitreal insert containing FAc, a non-proprietary corticosteroid with demonstrated efficacy in the treatment of ocular disease. ILUVIEN is in development for the treatment of DME, a disease of the retina that affects individuals with diabetes and can lead to severe vision loss and blindness.

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 future results of operations and financial position, business strategy and plans and objectives of management for Alimera's future operations. Words such as "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "contemplate," "predict," "project," "target," "likely," "potential, " "continue, " "will," "would," "should, " "could," or the negative of these terms and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The events and circumstances reflected in Alimera's forward-looking statements may not occur and actual results could 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, delay in or failure to obtain regulatory approval of Alimera's product candidates, uncertainty as to Alimera's ability to commercialize, and market acceptance of, its product candidates, the extent of government regulations, uncertainty as to relationship between the benefits of Alimera's product candidates and the risks of their side-effect profiles, dependence on third-party manufacturers to manufacture Alimera's product candidates in sufficient quantities and quality, uncertainty of clinical trial results, limited sales and marketing infrastructure, inability of Alimera's outside sales force to successfully sell and market ILUVIEN in the U.S. following regulatory approval and Alimera's ability to operate its business in compliance with the covenants and restrictions that it is subject to under its credit facility, 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, 2010, and Quarterly Report on Form 10-Q for the quarter ended June 30, 2011, 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.

CONTACT: For press inquiries:

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Source: Alimera Sciences, Inc.

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