pSivida Corp says its licensee Alimera Sciences has been notified that the US FDA has granted Priority Review status for the New Drug Application filed for Iluvien for the treatment of diabetic macular edema.
FDA Priority Review 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.
President and CEO Dr Paul Ashton said: "With priority review, a response from the FDA regarding Iluvien could be received in the 4th quarter of this year that would trigger a $US25 million milestone payment to pSivida from Alimera. pSivida will also receive 20% of net profits on sales by Alimera."
pSivida continues to work to develop new products for the sustained release of drugs and proteins based on its existing and new technologies.
Pfizer and pSivida are also collaborating to develop opthalmic products based on PSD technology. pSivida's intellectual property consists of more than 50 patent families, more than 100 granted patents including patents accepted for issuance and more than 150 patent applications.
Source: News Bites
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