pSivida (NSDQ:PSDV) said yesterday that the FDA plans to review the company’s application for its drug-releasing ocular insert, Durasert. The product is designed to provide three years of treatment for patients with posterior segment uveitis.
The U.S. regulatory agency is slated to decide whether or not to approve pSivida’s new drug application by Nov. 5.
“The FDA’s acceptance for review of our Durasert NDA submission is a major milestone for pSivida and we look forward to continuing to work with the FDA as they review our application,” president & CEO Nancy Lurker said in prepared remarks.
The Watertown, Mass.-based company’s NDA included data from two successful late-stage trials, including a 153-patient Phase III trial that found there was a significant reduction in the recurrence of posterior segment uveitis through 12 months in the group treated with pSivida’s tiny, drug-releasing ocular insert.
Just 37% of people treated with Durasert experienced a recurrence compared to 71.2% of patients in the control group, pSivida reported last month. The portion of patients who required medication to lower their intraocular pressure during the 12 months of follow-up was 50.5% for the Durasert group and 51.9% for the control group. Just one patient, who was treated with Durasert, needed IOP surgery.
“Given the high unmet medical need, we believe that Durasert, if approved, has the potential to become an important new treatment option for the thousands of patients suffering from posterior segment uveitis, the third leading cause of blindness,” Lurker added.
Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.