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Alimera Sciences Reports Fourth Quarter 2012 Financial Results
Date:3/21/2013

ttee at NICE is expected to assess the impact of the ILUVIEN PAS on ILUVIEN's cost effectiveness and determine whether an update to the recently published final guidance is warranted.

"The interaction with NICE is proceeding as we expected and we believe that the ILUVIEN PAS could result in a change in NICE guidance," said Mr. Myers. "In both Germany and the UK we have added experienced resources to address market access challenges that other ophthalmology companies have similarly had to navigate."

FDA UpdateAlimera intends to resubmit its New Drug Application for ILUVIEN to the U.S. Food and Drug Administration (FDA) by the end of March.  Using data from Alimera's two previously completed pivotal Phase III clinical trials (FAME™ Study), the resubmission will focus on the safety aspects of ILUVIEN and the population of patients with chronic DME, the same group for which marketing approval for ILUVIEN has been granted in various EU countries.  Alimera will communicate any new PDUFA date once it is known.

Fourth Quarter 2012 Financial Results Research and development expenses for the fourth quarter of 2012 increased to $2.3 million, compared to $1.4 million for the fourth quarter of 2011. The increase was primarily attributable to the preparation of the resubmission of the NDA for ILUVIEN with the U.S. FDA expected in the first quarter of 2013.

For the full year ended December 31, 2012, research and development expenses increased to $7.9 million, compared to $7.1 million for the full year 2011.

General and administrative expenses in the fourth quarter of 2012 were $2.1 million, compared to $1.4 million in the fourth quarter of 2011. The increase was primarily attributable to infrastructure build in Europe in preparation for the launch of ILUVIEN in 2013. 

Marketing expenses in the fourth quarter of 2012 were $3.8 million, compared to $3.1
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SOURCE Alimera Sciences, Inc.
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