pSivida progressing market access for Medidur

Company News

pSivida (ASX:PVA), a company involved in the development of sustained release drug delivery products for treating eye diseases, has reported its results for the three months to December 2015.

The company said the quarter was highlighted by positive topline results reported from the first of two Phase 3 trials of its lead product candidate Medidur for posterior uveitis.

The company said its 129 patient, multi-centre, randomised and double-masked trial met its primary efficacy endpoint of prevention of recurrence of disease at six months with high statistical significance. Safety results were also positive.

"Exploratory analyses of Medidur-treated eyes relative to control through six months also showed statistical significance for improvement in visual acuity (gain of 15 or more letters on the ETDRS Eye Chart), prevention of vision loss (loss of 15 or more letters) and reduction in systemic therapy," said the company in a statement.

pSivida said it intends to file for marketing approval in Europe based on data from the single Phase 3 trial. The UK regulator has advised pSivida that an application for a product treating a condition like posterior uveitis could be based on statistically compelling and clinically relevant results from just one pivotal trial.

"We believe that the level of statistical significance achieved in our first Phase 3 trial results should permit us to file our EU marketing approval application based on those results, accelerating the timing of planned submission toward the end of this year, rather than in 2017 as was originally planned," said Paul Ashton, PhD, president and CEO of pSivida.

"We have also requested a meeting with the US Food and Drug Administration (FDA) to confirm, in light of our first Phase 3 trial results, that data from two trials will continue to be required for our U.S. New Drug Application (NDA), currently planned for the first half of calendar 2017," added Dr Ashton.

As at the end of 2015, pSivida reported cash, cash equivalents and marketable securities totalling $21.1 million, compared to $24 million at the end of the prior quarter.

The company subsequently completed a $17.8 million underwritten public offering of common stock.

"With the addition of approximately $16.4 million of net proceeds from the offering, we believe we are in a position to continue our planned operations past the planned Medidur NDA filing and into the fourth quarter of calendar 2017," said Dr Ashton.

"Net cash usage in the fiscal 2016 second quarter was less than the prior quarter due to the timing of CRO payments for Medidur clinical development and, to a lesser extent, proceeds from stock option exercises, refundable foreign tax credits and the absence of incentive compensation awards paid in the prior quarter," said the company.

pSivida also announced the resignation of Mr Peter Savas from its Board. Mr Savas had been a member of the company's Board since 2008.