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pSivida's New Iluvien Approval Attempt Focuses on Safety

Tue, 04/02/2013 - 2:53pm
Mass Device

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.

pSivida

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.

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