pSivida announced the Data Safety Monitoring Board’s approval of the continuation of the two significant Phase III clinical trials known as FAME(TM).

The two FAME trials, (Fluocinolone Acetonide in Diabetic Macular Edema) do not require any changes according to the DSMB’s evaluation and will continue under their current protocol. They are studying the treatment of diabetic macular edema (DME) with Medidur(TM) FA, which will be marketed under the name Iluvien(TM).

The FAME studies are duplicate, double-blinded, randomized multicenter studies of 956 patients in the U.S., Canada, Europe and India. The 36 month-long study is in preparation of planned global registration filing and safety will be assessed in a follow-up after two years. Enrollment for the study was completed in October 2007 and all patients have been followed for anywhere between one and over two years.

Medidur(TM) is a tiny injectible insert and is being studied as a means of delivering the corticosteroid, fluocinolone acetonide to the retina for a period of up to three years as a treatment for DME. An outpatient treatment, the insert is injected into the vitrious by an eye care professional.

Nearly 8% of the US population has diabetes and almost all diabetics develop some type of diabetic retinopathy, including DME. The company estimates that as many as one million people suffer from DME in the U.S., for which there are currently no approved drug treatments.

Source: pSivida Corp.