pSivida announced it has submitted its new drug application (NDA) to the FDA for Durasert 3-year treatment for posterior segment uveitis. The NDA includes data from two phase 3 studies that each successfully achieved the primary efficacy endpoint at 6 months with a P < .001. In addition, the safety profile of patients treated with Durasert 3-year posterior segment uveitis treatment was consistent with the safety profile of steroid treatments that are currently considered standard of care for this disease.
“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,” Nancy Lurker, President and CEO, said in a company news release. “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.”
The FDA will next determine whether pSivida’s NDA is complete and acceptable for review; this procedure is typically completed within 60 days from the original NDA submission date.