pSivida's new Iluvien approval attempt focuses on safety

April 2, 2013 by Arezu Sarvestani

Massachusetts medical device maker pSivida is highlighting the safety of its Iluvien drug-device combination in hopes of finally winning FDA approval for treating patients with diabetic macular edema.


Alimera Sciences

Watertown, Mass.-based pSivida (NSDQ:PSDV) and its licensee Alimera Sciences submitted a new response to the FDA in hopes of highlighting the safety profile of the Iluvien chronic diabetic macular edema treatment, a drug-device combination that the federal watchdog agency rejected in November 2011.

As promised, the companies submitted new information for their New Drug Application, offering clinical data gleaned from the completed phase III FAME trial, according to a press release.

Sign up to get our free newsletters delivered right to your inbox.

The new results focus on patients with DME who didn't respond to conventional therapy, the same patient group that European regulators used to green-light the therapy in the U.K.

The new application l is particularly meaningful for pSivida, which has a $25 million milestone payment hinging on approval.

"We are pleased to see the resubmission of the NDA to the FDA," pSivida president & CEO Dr. Paul Ashton said in prepared remarks. "To date, we have received over $30m from Alimera from its license of Iluvien for DME, and if the FDA approves Iluvien, we would be entitled to an additional $25 million milestone payment as well as 20% of net profits, as defined, on any sales in the U.S. by Alimera."