Positive top-line results from first Phase III trial of pSivida's Medidur

Shares of Australian ophthalmic drug delivery specialist pSivida (ASX: PVA) gained 2.3% to A4.02 in early trading today, after positive top-line results of two Phase III studies with its Medidur were presented at the American Society of Retinal Specialists Annual Meeting, on Sunday, August 14, in San Francisco.

The first of pSivida’s two Phase III trials was of Medidur for recurrent non-infectious uveitis affecting the posterior segment of the eye, the trial through its six-month primary endpoint and through 12 months of follow-up.

This was the first scientific presentation of the top-line results from this Phase III trial, which met its primary end point, prevention of recurrence of disease at six months, with high statistical significance (p less than 0.00000001, intent to treat analysis) maintained through 12 months. In addition to data on prevention of recurrence of disease, Data were presented data on additional exploratory analyses on improvement of visual acuity, elimination of systemic treatments (which can cause serious side effects), and safety results including incidence of cataract and elevated intraocular pressure (which can be a result from the disease itself as well as from steroid treatment).