pSivida Phase 3 trial of Medidur meets enrollment target
pSivida announced that its second Phase 3 trial of Medidur in chronic, non-infectious posterior segment uveitis met its target enrollment of 150 patients. The trial is being conducted in clinical sites in India, with the same study design and endpoints as the first Phase 3 trial conducted in the U.S., EU and India. The results of both Phase 3 trials will support U.S. product registration, with NDA submission planned for the second half of 2017. Filing for EU registration remains on track for Q1 of 2017. This first Medidur trial met the primary efficacy endpoint of prevention of recurrence of posterior segment uveitis at six months in December 2015. Primary efficacy endpoint readout in the second study is expected in the second half of 2017.