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.
Alimera Sciences
FDA rejects Iluvien, pSivida-Alimera's drug-device eye treatment
pSivida Corp. (NSDQ:PSDV) partner Alimera Sciences Inc. (NSDQ:ALIM) received a rejection letter from the Food & Drug Administration for their drug-device combination Iluvien.
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.
FDA grants pSivida, Alimera expedited review for macular degeneration treatment
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, Alimera file EU NDA for macular degeneration treatment
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.
Alimera repays $15 million pSivida note
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.
