Iluvien approved in 10th EU market: pSivida

pSivida (ASX:PVA) licensee Alimera Sciences has received marketing authorisation in its 10th European country for diabetic macular oedema (DMO) treatment Iluvien.

The Swedish Medical Products Agency has approved the treatment - which uses an ocular micro-insert designed by pSivida - under the EU’s Mutual Recognition Procedure.

As with the other European markets, the approval covers patients with chronic DMO considered insufficiently responsive to available therapies.

Iluvien has also been approved in Austria, Denmark, France, Germany, Italy, Norway, Portugal, Spain and the UK, and is commercially available in the UK and Germany.

Approvals are also pending in Belgium, the Czech Republic, Finland, Ireland, Luxembourg, the Netherlands and Poland.

Outside of the EU, the US FDA plans to decide by 26 September whether to approve the product for that market. pSivida will be entitled to a US$25 million ($27.1 million) payday if the FDA approves the treatment.

pSivida separately revealed that its revenue for the financial year ending in June grew 66.6% to US$3.5 million. The company attributed the gain primarily to “recognition of US$1.5 million of consideration from a feasibility study agreement”.

The company’s net loss grew to US$13.4 million from US$11.9 million but pSivida still ended the year with a cash position of around US$18.3 million, up from US$10.3 million a year earlier.

pSivida (ASX:PVA) shares were trading 0.79% lower at $5.04 as of around 2 pm on Wednesday