PSivida's eye disease drug submitted to FDA
Watertown-based biotechnology company pSivida Corp. has announced that its diabetic macular edema drug (DME) product, Iluvien, has been submitted to the U.S. Food and Drug Administration, with a request for priority review, by licensee Alimera Sciences Inc.
PSivida developed the drug and licensed it to Alpharetta, Ga.-based Alimera in 2005, and it has joint ownership and reference rights to the NDA. If approved by the FDA, pSivida stands to receive a $25 million milestone payment from Alimera Sciences, in addition to 20 percent of Iluvien’s net profits of sales.
Iluvien is an insert containing the corticosteroid, fluocinolone acetonide, that goes into the eye of someone with diabetic macular edema, a disease which causes progressive loss of sight.
The company is finishing clinical trials across the U.S., Canada, Europe and India to measure the safety of Iluvien in treating DME, expected to be completed this year.
The licensee Alimera noted in a press release today that it expects to submit registration filings, following the NDA, with Canada and some European countries;
In April, pSivida (Nasdaq: PSVD) announced that it had taken in a $15 million payment from Alimera to cover the licensing of Iluvien.