Another European regulatory milestone for pSivida's Iluvien

pSivida (ASX:PVA), and its partner Alimera Sciences, is just one country away from a European sweep following the Spanish regulators giving Iluvien approval for sale.

The Spanish Agency of Drugs and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios) granted marketing authorisation for the sale of Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies.

It follows similar approvals from the United Kingdom, Austria, Portugal, France and Germany.

Only Italy remains tardy in announcing its decision of whether or not to approve Iluvien for sale in that country. Alimera is currently working with the Italian authorities to help secure the regulatory tick.

"We are pleased that Iluvien has now been granted marketing authorisations in six of the seven EU countries in which approval has been sought and look forward to its commercial launch in the EU," said Dr Paul Ashton, president and CEO of pSivida.

Alimera now has its European management team in place and is winding up for a Q1 2013 launch of the product starting in Germany and then expanding to other jurisdictions.

pSivida is also on track for issuing a new New Drug Application with the US Food and Drug Administration after receiving a knockback in 2011 for providing insufficient safety data.

pSivida's (ASX:PVA) stock has remained steady at $1.30 as of around 10.30am Friday.