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Alimera Announces Positive Results From the Two Phase 3 FAME(TM) Trials of Iluvien(R) in Patients With Diabetic Macular Edema
Date:12/23/2009

ated in the study. Intraocular pressure (IOP) increases of 30 millimeters of mercury (mmHg) or greater at any time point, a key adverse event studied in the trial, were seen in 16.3% of the low dose patients and 21.6% of the high dose patients. Over the 24 month period, 2.1% of patients receiving the low dose and 5.1% of the patients receiving the high dose had undergone a trabeculectomy (filtration procedure) to reduce their eye pressure.

Based on these and other data, Alimera plans to seek approval of the low dose of Iluvien for the treatment of DME in the second quarter of 2010, followed by registration filings in various European countries and Canada. Submission of the NDA will be based on the month 24 safety and efficacy data while the FAME Study will continue to month 36.

"I am very proud of the Alimera team for having completed trials which we believe demonstrate efficacy at the month 24 clinical readout and am confident that we will submit an NDA application for Iluvien in 2010 for the treatment of DME. If approved, we believe this would be the first drug approved for the treatment of this condition," said Dan Myers, president and CEO of Alimera Sciences. "Additionally, we appreciate the efforts of our clinical sites around the world that have managed and continue to manage the patients in the FAME Study."

In addition to the analysis described above, as prospectively planned in the protocol, Alimera also conducted several other analyses of the 24 month data. These included a) an All Randomized and Treated (ART) analysis of the 24 month data that includes data from all subjects randomized and treated with values imputed for all missing data using the LOCF method, and b) a Modified ART analysis that utilizes the ART population, but excludes data collected subsequent to the use of treatments prohibited by protocol (such as intravitreal injections of Avastin, Lucentis or triamcinolone acetonide) with the last observ
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SOURCE Alimera Sciences, Inc.
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