pSivida Corp. has announced that after completing its review of safety and efficacy data currently available, an independent Data Safety Monitoring Board (DSMB) has once again recommended that the two pivotal Phase III clinical trials, known collectively as the FAME (Fluocinolone Acetonide in Diabetic Macular Edema) Study continue under the current protocol, without change.
The trial is studying the use of Medidur FA for the treaent of diabetic macular edema (DME) being conducted by our licensing partner, Alimera Sciences. Medidur FA will be marketed under the name Iluvien.
FAME are two, duplicate, double-masked, randomized, multi-center studies following 956 patients in the U.S., Canada, Europe and India for 36 months in support of a planned global registration filing, with safety and efficacy assessed after two years of follow-up. Enrollment for the FAME study was completed in October 2007. All patients have now been followed for at least approximately one year and many have been followed for two or more years.
“pSivida is very pleased that the DSMB has once again supported the continuation of this pivotal trial and remains on track to file an NDA for this product in early 2010,” said pSivida Managing Director, Dr. Paul Ashton. “Following the recent amendment to the licensing agreement with our development partner, we continue to have a significant financial interest in Iluvien and other products developed under this agreement without an obligation to fund the development of the products.”
In March, pSivida announced that it had amended its licensing agreement with development partner, Alimera Sciences to reduce its share in the future profits of Medidur FA from 50% to 20% in return for consideration of up to approximately $78m from Alimera.
Medidur, a tiny, injectable insert, is being studied as a way to deliver fluocinolone acetonide, a corticosteroid, to the retina for up to three years as a treaent for diabetic macular edema (DME). Using a proprietary 25 gauge injector system, an eye care professional injects the Medidur insert into the vitreous through a minimally invasive procedure in an outpatient setting.
Currently, nearly 8 percent of the US population has diabetes. Over time, almost all diabetics will develop some form of diabetic retinopathy, of which diabetic macular edema is the primary cause of vision loss. Based on published data, pSivida estimates that in the United States as many as 300,000 people are diagnosed with DME each year and an estimated 1,000,000 people suffer from DME. Currently, there are no FDA approved drug treaents for DME.
A DSMB provides an independent evaluation of all trial data to identify potential safety issues that might warrant modification or early termination of ongoing studies. The FAME DSMB, a group comprised of four ophthalmologists and a biostatistician, met to review the Medidur FA Phase III clinical trial data. The DSMB’s charter stipulates that a formal review occur every six months in addition to their ongoing review of the trial.