A new drug application (NDA) was filed for Medidur for posterior uveitis based on 6-month efficacy data for both phase 3 trials, according to a pSivida news release. The FDA 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 6-month efficacy data from the second trial. As 6-month visits in the first trial will be completed this month, top-line results from the first phase 3 trial are now anticipated to be reported in December 2015. Enrollment in the second phase 3 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 6-month efficacy data,” Paul Ashton, PhD, president and CEO of pSivida, said in the news release. “The primary end-point of the phase 3 trials is recurrence of disease, which in the majority of patients occurs typically within 6 months. Our analysis of the masked data from our first trial is consistent with this. We believe therefore that 6-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.”