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.
To glean positive results from the new FAME trials,pSivida focused on safety for patients with chronic diabetic macular edema who do not respond to conventional therapy – the same patient group that European regulators used to green-light the therapy there, according to a press release. pSivida said it’s waiting to hear from Germany’s Medicine & Health products agency to begin commercializing Iluvien.
pSivida suffered a blow in November, when the U.K.’s National Institute for Health and Clinical Excellence struck down Illuvien because of its expense. Alimera reported that a compromise patient access scheme is now under review by the U.K.’s regulatory agency and that it expects to begin shipments to the U.K. during the 2nd quarter for privately insured patients.