pSivida plans for NDA filing for Medidur based on six-moth data

Australian ophthalmic drug delivery specialist pSivida (ASX: PVA) says it now plans to file a New Drug Application for Medidur for posterior uveitis based on six-month efficacy data for both Phase III trials.

The US Food and Drug Administration has advised pSivida that this data will be acceptable for review by the agency. pSivida previously planned to utilize 12-month efficacy data from the first trial and six-month efficacy data from the second trial. As six-month visits in the first trial will be completed this month, top-line results from the first Phase III trial are now anticipated to be reported in December 2015. Enrollment in the second Phase III trial continues and is expected to be completed during the first half of 2016, with an NDA anticipated in the first half of 2017.

“We are very pleased that the FDA has agreed to review an NDA for posterior uveitis based on six- month efficacy data,” said Paul Ashton, president and chief executive of pSivida. “The primary end-point of the Phase III trials is recurrence of disease, which in the majority of patients occurs typically within six months. Our analysis of the masked data from our first trial is consistent with this. We believe therefore that six-month data from our two trials will show safety and efficacy. We look forward to being able to announce the top-line results from the first trial at the end of this year,” he added.