pSivida licensee gets Italian approval for Iluvien

pSivida (ASX:PVA) licensee Alimera Sciences has secured marketing authorisation in Italy for ocular insert Iluvien as a treatment for diabetic macular oedema.

The Italian Medicines Agency has approved Iluvien as a C Class product, meaning it is initially only available for private pay patients. But Alimera is seeking H Class designation for Iluvien, which would expand patient access to the treatment.

Besides Italy, Alimera has now secured approval for the product in Austria, the UK, Portugal, France, Germany and Spain, and commercially launched it in the UK and Germany. 

The company is also pursuing arrangements through the EU’s Mutual Recognition agreements to gain approval in another 10 EU markets.

In the US, Alimera is awaiting the FDA’s decision on its fourth new drug application for the product. The agency has set a Prescription Drug User Fee Act (PDUFA) date of 26 September. 

If the FDA approves Iluvien, pSivida will be eligible for a US$25 million milestone payment as well as royalties on sales.

pSivida is separately at the phase III trial stage for Medidur, a treatment for posterior uveitis that uses the same micro-insert as Iluvien.

pSivida (ASX:PVA) shares were trading 2.41% higher at $4.25 as of around 1 pm on Wednesday.