Irish marketing authorised for ILUVIEN

THE ROADHOUSE PHARMACY: pSivida Corp. (ASX: PVA) announced the Irish Health Products Regulatory Authority (HPRA) has granted marketing authorisation to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

The company said the Irish grant marks the 13th country in which ILUVIEN has been approved for commercialisation.

In the European Union (EU), ILUVIEN is currently marketed in the United Kingdom and Germany and is scheduled to launch in Portugal this year.

pSivida declared ILUVIEN has marketing approval in 12 EU countries and is pending approval in five others.

ILUVIEN was recently approved in the United States for treatment of DME, where it is expected to be commercially available by early 2015.

pSivida explained ILUVIEN is indicated for patients previously treated with a course of corticosteroids who did not have a clinically significant rise in intraocular pressure (IOP).

“We are pleased that ILUVIEN has continued to gain marketing approvals in Europe as well as the US,” pSivida president and CEO Dr. Paul Ashton said in the company’s announcement to the Australian Securities Exchange.

“We believe ILUVIEN’s efficacy and three-year duration will make it an attractive treatment option for many DME patients, particularly in the US where the drug has broader labeling.”

pSivida is entitled to 20 per cent of the net profits from sales of ILUVIEN by its licensee on a country-by-country, quarter-by-quarter basis.

Website: www.psivida.com