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Early safety data favorable for pSivida’s Medidur for posterior uveitis

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Early IOP safety data are encouraging for Medidur, a treatment for posterior uveitis in phase 3 trial, pSivida announced in a press release.

At 3 months, only 4% more study eyes demonstrated elevated IOP than did fellow eyes that did not receive Medidur, the release said. Assessment data on IOP elevation to greater than 21 mm Hg were available for 105 of 129 enrolled subjects. The trial’s primary endpoint is recurrence of posterior uveitis within 1 year.

Medidur is a 3-year sustained-release microinsert of fluocinolone acetonide, a corticosteroid.

“The minimal difference observed in elevated IOP in the assessment suggests highly favorable results for a key safety measure of the trial, the number of eyes that develop clinically significant increases in IOP within 12 months of receiving Medidur relative to control eyes,” the release said.

Top-line results are expected in the second quarter of 2016, and a second phase 3 trial has been initiated in India to assess recurrence of posterior uveitis within 6 months, according to the release.