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pSivida plans to submit NDA for Medidur using 6-month efficacy data

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pSivida plans to submit a new drug application to the FDA for Medidur to treat posterior uveitis, according to a press release.

The NDA, expected to be submitted in the first half of 2017, will be based on 6-month efficacy data of Medidur (sustained-release micro-insert of fluocinolone acetonide) from two phase 3 clinical trials that the FDA said will be acceptable for review, the release said.

“The primary endpoint 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,” Paul Ashton, PhD, president and CEO of pSivida, said in the release.

pSivida anticipates reporting results from the first phase 3 trial in December and continues to enroll patients in the second phase 3 trial, which the company expects to be completed in the first half of 2016.