The drug-delivery product’s NDA includes data from two Phase III trials, both of which met their primary efficacy endpoints after six months.
pSivida’s Durasert product also boasts a safety profile consistent with that of the steroid treatments considered standard of care for posterior segment uveitis, according to the Watertown, Mass.-based company.
“We have previously developed and out-licensed three sustained-release treatments for other back-of-the-eye diseases, all of which received FDA approval. This positive track record is an asset as we enter this next phase of development for our company’s first commercial product,” president & CEO Nancy Lurker said in prepared remarks.
“Durasert is our lead product candidate for the treatment for posterior segment uveitis, the third leading cause of blindness. 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 three months with much higher costs. On behalf of everyone at pSivida, I want to thank the retinal specialists and patients for being involved in the studies as their commitment demonstrates the severity of uveitis as a condition with a significant unmet need. We look forward to the FDA’s review process for our submission.”