Alimera Sciences, Inc. (Nasdaq:ALIM) ("Alimera"), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that a new analysis of data from its Phase 3 (FAME) clinical trials for Iluvien, the company's investigational intravitreal insert being studied for diabetic macular edema (DME), indicates that patient vision continues to improve significantly over 30 months. This new analysis was presented at the Citi Investment Research Global Health Care Conference in New York at 2:30pm on May 27th, 2010. A replay of the webcast will be available at www.alimerasciences.com through August 25, 2010.
The analysis focused on the primary efficacy variable of the number of patients who improved by 15 letters or more, based on observed cases. At month 24, 31% of the low dose patients (p value of 0.003) had improved vision of 15 letters or more and at month 30, with a sample size of 123 patients, an improvement in visual acuity of 15 letters or more was seen in 40% of the patients (p value of 0.002). (See Exhibit 1). Statistical significance versus control was seen by three weeks among the observed cases, and this significance was maintained through month 30. The complete 36-month dataset will be presented after the trial concludes in October 2010.
"While there have been some exciting developments of late in investigational DME therapies, this preliminary, 30-month observed cases data for Iluvien is of significant interest to retinal physicians," said Barry Kuppermann, M.D., Ph.D, Professor and Chief of the Retina Service at University of California, Irvine. "For patients to continue to have vision improvement, at this level, up to 30 months after first receiving Iluvien is impressive."
Alimera is currently conducting two 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, a high and low dose, in the treatment of DME. In December 2009, the month 24 clinical readout from the FAME Study was completed and announced. Alimera plans to file a New Drug Application (NDA) in the United States for the low dose of Iluvien in the second quarter of 2010, followed by registration filings in certain European countries and Canada.
"We believe the combination of the early visual acuity gains among this diabetic population and the long-term sustained improvement with Iluvien beyond 24 months will make Iluvien a very viable option to treat DME," said Dan Myers, President and CEO of Alimera. "We are working diligently to prepare our submission to the FDA in the second quarter of 2010 and if reviewed favorably, Iluvien will be the first pharmacological treatment indicated for DME."
Exhibit 1. Percent of patients achieving greater than or equal to15 letters of visual acuity improvement using the observed cases method.
A graph accompanying Exhibit 1 is available at http://media.globenewswire.com/cache/12565/file/8309.pdf
Although both a low and high dose of Iluvien were studied in these trials, only the low dose is shown in Exhibit 1 as Alimera intends to commercialize this dose if approved by the FDA. In the previous dataset presented, data imputation employed the "last observation carried forward" (LOCF) method, for data missing because of patients who discontinued the trial or were unavailable for follow-up. In the analysis presented today, no data imputation was employed and only "observed cases" were considered in which only those patients for whom data was available at the clinical visit were analyzed.
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