dsmb again supports continuation of the phase

ASX/Media Release
DSMB AGAIN SUPPORTS CONTINUATION OF THE PHASE III CLINICAL
TRIAL OF MEDIDUR™ FA FOR THE TREATMENT OF DME
Boston, MA and Perth, Australia (March 25, 2008) – pSivida Limited (NASDAQ:PSDV, ASX:PSD,
Xetra:PSI) today 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 can 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 two, duplicate, double-masked, randomized, multi-center studies that are 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. Enrolment for the
FAME study was completed in October 2007.
“pSivida is very pleased that the DSMB has supported the continuation of this pivotal trial and we
remain 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 Medidur FA and other products
developed under this agreement without an obligation to fund the development of the products.”
Earlier this month, pSivida announced that it has 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 US$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 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, 7.5 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. In the United States, as many as 200,000 people are diagnosed with DME each
year and an estimated 1,000,000 people suffer from DME. Currently, there are no FDA approved
drug treatments 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.
-ENDS