Iluvien Update 7: Alimera Sciences to Re-File for FDA Approval of Iluvien for Chronic DME

Since my last update in April (Update 6), when the first country, Austria, of an anticipated seven European Union country market approvals was announced, four additional EU approvals have occurred, bringing the total of approvals to five – with Austria, France, Portugal, Germany, along with the United Kingdom. Only Italy and Spain remain of the original seven EU countries where approvals were expected.

As I first reported back in November 2011 (Update 4), the FDA had turned down Alimera’s resubmitted NDA application for approval, stating that questions remained based on the data previously submitted, about the (Read more...)

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