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Alimera Sciences Reports Second Quarter 2014 Financial Results
Date:8/7/2014

We continue to have strong relationships with contract sales organizations in other EU countries, and as we expand to other markets we will implement contract, direct or hybrid sales models depending on the unique characteristics of that market."

"We continue to make strong progress in our geographic expansion efforts and remain on track to launch ILUVIEN in Portugal and France during the fourth quarter of 2014. In June 2014, the Italian Medicines Agency granted marketing authorization to ILUVIEN. We also received a positive outcome of the Repeat-Use Procedure for ILUVIEN in 10 additional EU countries, and we are working closely with these countries during the national phase to obtain ILUVIEN marketing authorization in each one. Recently, Norway and Denmark became the first countries to grant national marketing authorization following the positive outcome in June of the Repeat-Use Procedure application."

As announced in April 2014, Alimera's resubmission of its new drug application (NDA) for ILUVIEN to the U.S. Food and Drug Administration (FDA) to address questions raised in the FDA's October 2013 complete response letter has been acknowledged by the FDA as a complete class 2 response and a Prescription Drug User Fee Act (PDUFA) goal date of September 26, 2014 had been established. In the October 2013 complete response letter, the FDA referenced deficiencies in the methods and controls used for the drug product at the third party facility where ILUVIEN is manufactured. In July 2014, the third party facility received a notification from the Los Angeles District of the Department of Health and Human Services (LA District) after their pre-approval and good manufacturing practice inspection of the facility in connection with Alimera's NDA. In that notification, the LA District recommended approval of the NDA by the FDA. This is only a recommendation which the FDA is not obligated to follow. Only the FDA can issue an official approval of the NDA.

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SOURCE Alimera Sciences, Inc.
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