pSivida (NSDQ:PSDV) started recruiting patients in a Phase III U.S. trial for its eyelash-sized drug/device combination, an implant designed to treat ocular swelling that can lead to blindness.
Alimera Sciences
pSivida wins approval for Iluvien in Germany
pSivida’s new Iluvien approval attempt focuses on safety
pSivida takes another stab at FDA approval for Iluvien
U.K. regulators deal pSivida, Alimera a blow
Slide continues for pSivida, Alimera after FDA rejection
pSivida-Alimera eye treatment still a no-go for the FDA
The FDA rejected pSivida Corp.’s (NSDQ:PSDV) and Alimera Sciences Inc.’s (NSDQ:ALIM) resubmitted new drug application for the Iluvien eye treatment, citing a lack of safety and efficacy data.
Iluvien is designed to deliver sustained, low doses of flucocinolone acetonide to the retina at the rear of the eyeball in patients with diabetic macular edema.
pSivida, Alimera want FDA to give eye treatment another look | Regulatory roundup
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.
