pSivida takes another stab at FDA approval for Iluvien

March 27, 2013 by Sony Salzman

As pSivida gears up to begin distribution of its Illuvien eye treatment in Europe, it plans to re-submit its new drug application to the FDA for the drug/device combination.

pSivida

Alimera Sciences

It's been a rocky road for pSivida's (NSDQ:PSDV) Illuvien, a drug/device combination for diabetic macular edema, but the company hopes that new trial data will pave the way to regulatory approval in the U.S.

Watertown, Mass.-based pSivida, which licenses the Iluvien technology to Alimera Sciences (NSDQ:ALIM), said the 2 companies plan to re-submit a new drug application to the FDA by the end of this month.

pSivida and Alimera will use data from 2 completed Phase III trials from the FAME study, which failed to prove safety in previous approval submissions. The federal watchdog agency originally rejected Iluvien back in November 2011 because FAME did not prove that the treatment's benefits outweigh its potential harm, sending shares sliding on Wall Street.

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

Comments

Built on an AdaptiveTheme using Drupal by Michael Knapp  mknapp