pSivida plans European regulatory filing for Medidur

Shares of US ophthalmic drugs maker pSivida (Nasdaq: PSDV) hit a new high on Monday, rising 8.5% to $4.74, after the company announced that it plans to file for European Union marketing approval of its injectable micro-insert Medidur for chronic non-infectious uveitis of the posterior segment of the eye (posterior uveitis). The implant contains the corticosteroid fluocinolone acetonide.

The submission will be based on data from a single pivotal trial as a result of the high statistical significance achieved in its first Phase III clinical trial. The release of these results last week already pushed pSivida’s shares up 28% (The Pharma Letter December 23).

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) advised pSivida that, consistent with the published Points to Consider (PtC) of the European Agency for Evaluation of Medicinal Products, 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.