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Tuesday, August 31, 2010

pSivida drug target gets FDA priority review

By Michelle Lang

The U.S. Food and Drug Administration has granted priority review status for the New Drug Application of Iluvien, the lead product of Watertown-based biotechnology company pSivida Corp. The drug candidate, which is intended to treat diabetic macular edema (DME), is licensed to Alpharetta, Ga.-based Alimera Sciences Inc.

If approved for priority review, pSivida and Alimera could have news of Iluvien’s status by fourth quarter this year, according to a news release from pSivida.

Approval of the drug could bring in a $25 million milestone payment to pSivida from Alimera, as well as 20 percent of Alimera’s net profits on sales of the drug. In April, pSivida took in a $15 million payment to cover the licensing of Iluvien.

PSivida (Nasdaq: PSVD) develops miniaturized, injectable drug delivery systems for eye patients. Its Iluvien is an insert containing the corticosteroid, fluocinolone acetonide, that goes into the eye of a patient with diabetic macular edema, a disease that causes progressive loss of sight. The company was launched in Australia, and reincorporated as a U.S. company based in Watertown in April of 2008.



 

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