(RTTNews) - Shares of pSivida Corp. (PSDV: News ), a drug delivery company with a primary focus on ophthalmology and oncology, set a new intra-day high of $3.58 for the year and then pulled back to close at $3.32 on Wednesday. At the Rodman & Renshaw Annual Health Care Conference in New York, September 10, Paul Ashton, president and chief executive officer of pSivida will make a presentation.
The company's lead development product --Iluvien for the treatment of diabetic macular edema is under two phase III trials. The trials, dubbed FAME study (Fluocinolone Acetonide in Diabetic Macular Edema), are being conducted in partnership with privately-held Alimera Sciences Inc.
Iluvien is an injectable, non-erodable, intravitreal implant designed to release the drug fluocinolone acetonide, or FA, for up to three years. According to pSivida, Iluvien is small enough to be injected into the back of the eye with a 25 gauge needle creating a self-sealing hole and the insertion procedure is very similar to an intravitreal injection, a procedure commonly employed by retinal specialists.
Diabetic macular edema, or DME, for which pSivida is testing Iluvien, is a common diabetes complication, which causes retinal blood vessels in a diabetic's eyes to deteriorate and leak.
In March, the company reported favorable 12-month interim safety and efficacy results from a 36-month, open-label, phase II study, which is running concurrently with the pivotal phase III trials. The 12-month results of the phase II study revealed that there were no adverse events related to intraocular pressure, or IOP, in low dose patients, and only 23.5% of the high dose patients experienced IOP increases of 30mm of mercury (mmHg) or greater at some time point.
According to pSivida, Iluvien compares favorably with Retisert as it has the potential to offer a very important safety advantage. Published results from clinical studies of DME patients who used Retisert show that 35% of the patients experienced IOP increases of 30 mmHg or greater at some time point during the first year.
Retisert, developed by pSivida was approved by the FDA in April 2005 for treating Uveitis, an intra-ocular inflammatory disease and is marketed under license by Bausch & Lomb.
The interim results presented in March also revealed that 27.3% of the high dose patients had an improvement in best corrected visual acuity, or BCVA of 15 letters or greater over baseline and 23.1% of the low dose patients had an improvement in BCVA of 15 letters or greater over baseline. The efficacy data of interim phase II results is from the subgroup of patients with the same visual acuity inclusion criteria as the larger phase III FAME trial.
