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.
The two companies are developing the system to treat diabetic macular degeneration. The investigational drug delivery system is designed for sustained release of Iluvien with an intra-vitreal insert.
The Food & Drug Administration put pSivida Corp. (NSDQ:PSDV) and Alimera Sciences Inc. (NSDQ:ALIM) on the fast track, granting an expedited review for their drug/device combination designed to treat diabetic macular edema.
Watertown, Mass.-based pSivida and Alpharetta, Ga.-based Alimera filed a new drug application with the FDA in June for Iluvien, a sustained release drug delivery system that delivers flucocinolone acetonide, a steroid, for the treatment of DME.
pSivida Corp. (NSDQ:PSDV) licensee Alimera Sciences (NSDQ:ALIM) submitted a Marketing Authorization Application in several European Union countries for Iluvien, an ophthalmic drug/device combination.
Iluvien is a sustained release drug delivery system that delivers flucocinolone acetonide, a steroid for the treatment of diabetic macular edema.
pSivida Corp. (NSDQ:PSDV) reeled a $15.3 million payment from Alimera Sciences Inc. (NSDQ:ALIM) triggered by Alimera’s April 21 initial public offering.
The two companies are collaborating on a drug-device combination called Iluvien, designed to treat diabetic macular edema. Last week Alimera raised $72 million in its IPO, selling 6.6 million shares at $11 each.