pSivida Corp.
pSivida takes another stab at FDA approval for Iluvien
pSivida and TechniScan drum up $10 million in private rounds
pSivida Corp. (NSDQ:PSDV) and TechniScan Inc. (OTC:TSNI) evidently wanted some privacy in their latest efforts to raise cash.
Watertown, Mass.-based pSivida, which develops ophthalmic drug-delivery devices, expects to net $9.9 million from an equity and warrant-based round involving a group of private investors, the company said today.
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.
pSivida's Q4 sales jump 388 percent
pSivida Corp. (NSDQ:PSDV) sailed into the black with a 388 percent increase in revenues during the fourth quarter of fiscal 2010.
The Watertown, Mass.-based ophthalmic drug-delivery device maker posted net earnings of $13.1 million, or 68 cents per diluted share, on sales of $15.7 million during the three months ended June 30. That compares with a net loss of $534,000, or 3 cents per diluted share, on sales of $3.2 million during the same period last year.
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 makes Russel Investment's microcap index
pSivida Corp. (NSDQ:PSDV) is touting its inclusion on Russell Investment Group’s Microcap Index.
According to the Watertown, Mass.-based maker of eye therapy implants, their selection means automatic inclusion in the "appropriate growth and value style indexes."
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.
pSivida aims to slow retinitis pigmentosa
pSivida Corp. (NSDQ:PSDV) is touting a study of a drug-device combination that it says helps slow the advance of a degenerative eye disease called retinitis pigmentosa.
The disease involves the gradual deterioration of the rods and cones that make up the retina. Symptoms begin with night blindness and progress over years or decades to tunnel vision and, often, total blindness. CEO Dr. Paul Ashton told MassDevice that the Watertown, Mass.-based company’s Durasert is inserted into the back of the eye, where it slowly releases a steroid called fluocinolone acetonide.