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.