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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

ation prior to protocol violation imputed to month 24 using the LOCF method.

The results of these separate analyses were as follows: by the ART analysis, in Trial A, 26.8% of low dose patients and 26.2% of high dose patients gained 15 or more letters at 24 months compared with 14.7% of control patients (p = 0.029 and 0.032, respectively). In Trial B of the ART analysis, 31.3% of high dose and 30.8% of low dose patients gained 15 or more letters compared with 17.8% of control patients (p = 0.028 and 0.026 respectively). The results for both doses in both trials were statistically significant. By the Modified ART method, in Trial A 22.6% of patients in the low dose and 24.1% of patients in the high dose gained 15 or more letters compared with 12.6% of control patients (p = 0.057 and 0.026, respectively). Trial A was not statistically significant for either dose. In Trial B by Modified ART, 29.7% of patients in the low dose and 29.3% of patients in the high dose gained 15 or more letters compared with 13.3% of control patients (p = 0.004 and 0.005, respectively). The results for both doses were statistically significant.

The FAME study protocol provides that the primary assessment of efficacy will be based on the Modified ART dataset and that the other datasets will be considered secondary; the protocol did not specify the Full Analysis Set as a dataset for analyzing the study. However, consistent with the FDA-adopted International Conference on Harmonization guidance, it is anticipated that the FDA will consider the Full Analysis Set to be the most relevant population for determining safety and efficacy in Trials A and B.

A more detailed analysis will be presented in February 2010 at the Angiogenesis, Exudation and Degeneration 2010 Meeting in Miami, Florida.

ALIMERA SCIENCES RECEIVES NOTICES OF EXERCISE FOR AN ADDITIONAL $10 MILLION IN EXTENDED SERIES C FINANCING

On August 24, 2009, Ali
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SOURCE Alimera Sciences, Inc.
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