MAY 20, 2015
Safety data from a phase 3 trial shows that a sustained-release flucinolone acetonide implant may not significantly increase IOP.
At 3 months, only 4% of eyes receiving the flucinolone acetonide implant (Medidur) experienced pressures higher than 21 mmHg compared with untreated fellow eyes.
pSivida Corp. says this minimal difference in elevated IOP suggests there will be highly favorable results for a key safety measure of the trial, the number of eyes that develop clinically significant increases in IOP within 12 months of receiving the implant.
"These data are very encouraging for the safety profile of Medidur," said Dr. Paul Ashton, president and CEO of pSivida Corp. "A significant treatment challenge with posterior uveitis patients is managing the serious side effects of prolonged steroid use, the current first-line treatment. A therapy that can provide the benefits of steroids on a sustained basis for 3 years with a single injection with a lower incidence of side effects would be a very significant advance in treatment of this disease."
A second Phase 3 trial for Medidur is currently underway. The company expects top-line results from the first Phase 3 study to be available during the second quarter of 2016 and to file for FDA approval during the first half of 2017.