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pSivida Corp 's Licensee Alimera Sciences, Inc. Reports Updates On ILUVIEN For Chronic Diabetic Macular Edema (DME).


Sunday, 24 Mar 2013 05:32pm EDT 

pSivida Corp announced that its licensee Alimera Sciences Inc, Inc. reported a number of updates with respect to ILUVIEN for chronic diabetic macular edema (DME). Alimera announced that it intends to resubmit its New Drug Application for ILUVIEN for DME to the U.S. Food and Drug Administration (FDA) by the end of March 2013. 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 considered insufficiently responsive to available therapies, the same group for which marketing approval for ILUVIEN has been granted in various EU countries, according to Alimera. Approval in the U.S. would entitle pSivida to a $25 million milestone payment from Alimera and 20% of net profits, as defined, from U.S. sales of ILUVIEN by Alimera. Alimera also announced that shipments of ILUVIEN to the German market are expected to begin in the second quarter of 2013 upon acceptance from the Medicine and Health products Regulatory Agency of the intended commercial batch size, a delay from Alimera’s previous expectation that this would occur in the first quarter of 2013. 

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