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Alimera Sciences provides new data from Iluvien Phase 3 FAME clinical trials for DME

March 20, 2017

"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 media.globenewswire/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.

SOURCE Alimera Sciences, Inc.