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Alimera Sciences Reports Third Quarter 2013 Financial Results
Date:11/11/2013

at the benefits of ILUVIEN did not outweigh its risks. The FDA suggested that a meeting with the Dermatologic and Ophthalmic Drugs Advisory Committee (Advisory Committee) may be of assistance in addressing these deficiencies and providing advice whether a patient population can be identified in which the benefits of ILUVIEN might outweigh its risks. Alimera was notified by the FDA, shortly after the issuance of the CRL, of the scheduling of a January 2014 meeting of the Advisory Committee. In a subsequent communication with the FDA, Alimera believes it clarified that the purpose of the Advisory Committee meeting is to consider the benefits and risks of ILUVIEN based on existing data available from Alimera's FAME™ Study. Alimera believes that if this were a positive meeting, it could lead to further discussions with the FDA regarding the potential approvability of the NDA.

In the CRL, the FDA also referenced deficiencies in the methods and controls used for the drug product at the facility where ILUVIEN is manufactured. Alimera does not believe that these deficiencies will affect its European commercial supply. Alimera and its third-party manufacturer are in the process of resolving these deficiencies.

"We look forward to the Advisory Committee meeting in January 2014 where we, together with retinal physicians, can discuss the benefits and risks of ILUVIEN in a public forum," said Mr. Myers.

Third Quarter 2013 Financial Results Total revenue for the third quarter of 2013 was $758,000, compared to total revenue of $179,000 for the second quarter of 2013, the quarter in which ILUVIEN was launched commercially in Germany and the United Kingdom.

Research and development expenses for the third quarter of 2013 decreased to $1.8 million, compared to $2.2 million for the third quarter of 2012. The decrease was primarily attributable to decreases of $320,000 in costs related to the completion of the enrollment of the physician utilizati
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SOURCE Alimera Sciences, Inc.
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