ATLANTA, Nov. 11, 2013 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced financial results for the third quarter ended September 30, 2013.
Total revenue from ILUVIEN, comprised of sales in Germany and the United Kingdom in the third quarter of 2013, increased 323% to $758,000, compared to second quarter 2013 revenue of $179,000.
In addition to its current activity in Germany and the United Kingdom, the Company anticipates a commercial launch of ILUVIEN in France in 2014. ILUVIEN is also approved in Austria, Portugal, and Spain, and pending approval in Italy. In the third quarter, Alimera submitted an application to the Medicines and Healthcare Products Regulatory Agency in the United Kingdom, as the Reference Member State, for 10 additional European Union (EU) country approvals through the Mutual Recognition Procedure, which could provide Alimera a pipeline for geographic expansion in the future. Alimera believes Europe offers the possibility of significant growth and estimates the market opportunity in Europe to be at least as large as that in the United States.
"During the third quarter, our commercial focus on Europe continued to grow as we increased revenue over 300% and expanded the number of physicians implanting ILUVIEN in their patients in Germany and the United Kingdom," said Dan Myers, Alimera's president and chief executive officer.
FDA UpdateOn October 17, 2013, Alimera received a Complete Response Letter (CRL) from the United States Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ILUVIEN. The FDA stated in the CRL that the NDA could not be approved in its present form, citing clinical and statistical deficiencies and indicated th
|SOURCE Alimera Sciences, Inc.|
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