pSivida Corp. (PSDV) announced its licensee, Alimera Sciences, reported the submission of its response to the second Complete Response Letter from FDA with respect to ILUVIEN for chronic diabetic macular edema. Alimera submitted the response, which includes additional analyses of the risks and benefits of ILUVIEN based on the clinical data available from the previously completed Phase III studies, following a meeting with the FDA in the second quarter 2012.
If the FDA approves ILUVIEN, pSivida would be entitled to a $25 million milestone payment as well as 20% of net profits, on any sales in the U.S. by Alimera.
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