pSivida (PSDV) Reports Favorable 12-Month Interim Safety and Efficacy Results from Iluvien

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March 12, 2009 10:41 AM EDT

pSivida Corp. (NASDAQ: PSDV) reported the interim 12-month safety and efficacy results from the first human pharmacokinetic study (PK Study) of Iluvien. The study is being conducted by the Company's licensing partner Alimera Sciences. Iluvien is an intravitreal insert being developed for the treatment of diabetic macular edema (DME).

This 36-month, open-label, Phase 2 study, running concurrently with the pivotal Phase 3 FAME(TM) Study (Fluocinolone Acetonide in Diabetic Macular Edema), is designed primarily to assess systemic exposure of the corticosteroid, fluocinolone acetonide (FA), after administration of Iluvien in patients with DME. Secondarily, the PK Study is designed to provide information on the safety and efficacy of Iluvien in a DME patient population. A total of 37 subjects were enrolled in the PK Study, 20 patients on the low dose of Iluvien (an approximate 0.23 micrograms (µg) per day dose), and 17 patients on the high dose of Iluvien (an approximate 0.45µg per day dose).

In the 12-month interim readout, no adverse events related to intraocular pressure (IOP) were seen in low dose patients, and 23.5 percent of the high dose patients experienced IOP increases of 30 millimeters of mercury (mmHg) or greater at some time point and one of those patients required surgery to address their elevated IOP. For comparative purposes, in published results from clinical studies of DME patients using sustained release intravitreal FA in Bausch & Lomb Incorporated's product Retisert(R) (a surgically implanted intravitreal drug delivery device containing 0.59 mg FA approved for the treatment of chronic non-infectious posterior uveitis), 35 percent of the patients experienced IOP increases of 30 mmHg or greater at some time point during the first year. [SM]