pSivida submits NDA for Durasert

A new drug application has been submitted to the FDA by pSivida for Durasert, its 3-year treatment for posterior segment uveitis, the company announced.

Two phase 3 trials have shown Durasert to reduce the recurrence of posterior segment uveitis in patients through 6 months of treatment.

“Our goal with Durasert is to provide relief to the thousands of patients suffering from this debilitating disease for which today’s standard of care is frequent injections of steroids or an implant that lasts up to 3 months with much higher costs,” Nancy Lurker, pSivida president and CEO, said in a press release.

The FDA recently waived the $2.4 million NDA fee for Durasert under a small business waiver of the Prescription Drug User Fee Act.

A new drug application has been submitted to the FDA by pSivida for Durasert, its 3-year treatment for posterior segment uveitis, the company announced.

Two phase 3 trials have shown Durasert to reduce the recurrence of posterior segment uveitis in patients through 6 months of treatment.

“Our goal with Durasert is to provide relief to the thousands of patients suffering from this debilitating disease for which today’s standard of care is frequent injections of steroids or an implant that lasts up to 3 months with much higher costs,” Nancy Lurker, pSivida president and CEO, said in a press release.

The FDA recently waived the $2.4 million NDA fee for Durasert under a small business waiver of the Prescription Drug User Fee Act.