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Alimera Sciences Reports First Quarter 2013 Financial Results
Date:5/9/2013

ough the National Health Service. The NICE Appraisal Committee is scheduled to meet on May 15, 2013 to discuss the ILUVIEN PAS and will communicate its decision at a later date.

FDA UpdateAlimera recently announced that its resubmission of the New Drug Application (NDA) for ILUVIEN has been acknowledged as received by the U.S. Food and Drug Administration (FDA) as a complete class 2 response to the FDA's November 2011 letter and that a new Prescription Drug User Fee Act (PDUFA) goal date of October 17, 2013 has been established. In the resubmission, Alimera responded to questions raised in the FDA's letter and provided additional analyses as well as new information to support that ILUVIEN is safe and effective in the treatment of patients with chronic DME. The resubmission focused on the safety aspects of ILUVIEN and the subgroup population of patients with chronic DME, the same subgroup for which marketing approval for ILUVIEN has been granted in six countries in the European Union. Alimera used existing data from two previously completed pivotal Phase 3 clinical trials (collectively called the FAME™ Study).

"We are pleased to have recently learned of the PDUFA goal date for our NDA for ILUVIEN in the fall and look forward to the FDA's response," said Mr. Myers.

First Quarter 2013 Financial Results Research and development expenses for the first quarter of 2013 increased to $2.0 million, compared to $1.6 million for the first quarter of 2012. The increase was primarily attributable to preparation of the resubmission of the NDA for ILUVIEN. In the event the FDA approves Alimera's NDA for ILUVIEN, Alimera will owe an additional milestone payment of $25.0 million to pSivida Corp.

General and administrative expenses in the first quarter of 2013 were $2.7 million, compared to $1.4 million in the first quarter of 2012. The increase was primarily due to infrastructure build and financial and operational planning for Alimera's
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SOURCE Alimera Sciences, Inc.
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