Singapore, Sep 1, 2010: pSivida, an Australian developer of sustained release drug delivery systems has announced the US Food and Drug Administration (FDA) has granted Priority Review status for the New Drug Application (NDA) filed for Iluvien for the treatment diabetic macular edema (DME).
The company's licensee, Alimera Sciences was notified about the priority review status. Such a status is given to therapies that offer major advances in treatment, or provide a treatment where no adequate therapy exists. This status reduces the review time goal from 10 months to six months.
Dr Paul Ashton, President and CEO of pSivida said, "With priority review a response from the FDA regarding Iluvien could be received in the fourth quarter of this year. Approval of Iluvien would trigger a $25 million milestone payment to pSivida from Alimera. Under the license agreement pSivida is also to receive 20 percent of net profits on sales by Alimera."
Last month, the company submitted the Marketing Authorization Application to the Medicines and Healthcare products Regulatory Agency (MHRA),United Kingdom. Applications have also been submitted to regulatory agencies in Austria, France, Germany, Italy, Portugal and Spain. Filing in Canada is expected to take place in September. pSivida has joint ownership and reference rights to these regulatory filings.
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