Perth-based biotechnology company pSivida Ltd will complete the third phase of trials of its diabetic macular edema treatment Medidur without change after an independent Data Safety Monitoring Board recommended it go ahead.
Perth-based biotechnology company pSivida Ltd will complete the third phase of trials of its diabetic macular edema treatment Medidur without change after an independent Data Safety Monitoring Board recommended it go ahead.
The full text of a company announcement is pasted below
After completing its review of safety and efficacy data currently available, an independent Data Safety Monitoring Board (DSMB) has recommended that the pivotal Phase III clinical trial 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 treatment of diabetic macular edema (DME).
FAME is a double masked, randomized, multi-center study that is following over 900 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.
Last week, Alimera and pSivida announced that enrollment for the FAME study is complete.
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.
"Alimera is pleased to have received the recommendation from the DSMB that the study proceed as planned," said Alimera CEO Dan Myers. "This recommendation further indicates that the development program for Medidur FA is on track for regulatory submissions in early 2010."
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 treatment 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, there are no FDA approved drug treatments for DME.
"We are very pleased that the DSMB has found no significant issues in the treatment of patients with Medidur over the past 18 months in the recruitment phase of this pivotal study," said pSivida Limited Managing Director, Dr Paul Ashton.
Currently, 7.5 percent of the US population is diabetic. Over time, almost all diabetics will develop some form of diabetic retinopathy, of which diabetic macular edema is the primary cause of vision loss. There are currently more than 500,000 people with DME in the United States and this number is expected to exceed 700,000 by the year 2010; approximately 75,000 new cases of DME are diagnosed each year.
