pSivida's marketing authorizations for Iluvien in 10 countries reaches next stage

Drug delivery specialists pSivida (Nasdaq: PSDV) says that the regulatory process for marketing authorizations of Iluvien (fluocinolone acetonide intravitreal implant) has entered the national phase in 10 European countries following the successful completion of the Mutual Recognition Procedure (MRP) for subsequent authorizations.

In the national phase, Belgium, the Czech Republic, Denmark, Finland, Ireland, Luxembourg, the Netherlands, Norway, Poland and Sweden will grant a marketing authorization for Iluvien for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Iluvien initially received marketing authorizations in Austria, France, Italy, Portugal, Spain as well as the UK and Germany where it is now commercially available.

Paul Ashton, president and chief executive of pSivida, said: “Continuing to expand the countries where Iluvien can reach patients with this devastating disease is important, and we look forward to the addition of these 10 countries.”