Iluvien launches in Germany
pSivida (ASX:PVA) licensee Alimera Sciences has launched diabetic macular edema (DME) treatment Iluvien in Germany.
The first German patient has been treated with the product - a sustained-release micro-insert designed to be implanted into the back of the eye.
Iluvien recently launched in the UK for private patients. The treatment has also been approved in Austria, Portugal and France, and is awaiting approval in Italy.
Alimera also recently resubmitted a New Drug Application for Iluvien with the US FDA - after the first application was met with a complete response letter requesting more clinical information - and the FDA has set a new PDUFA date for deciding on the application of 17 October.
pSivida CEO Dr Paul Ashton said the recent milestones with Iluvien could prove lucrative for his company.
“We will be entitled to 20% of net profits, as defined, in each of Germany and the UK from sales of Iluvien by Alimera,” he said. “If the FDA approves Iluvien, we would also be entitled to an additional $25 million milestone payment from Alimera as well as 20% of net profits on any sales in the US by Alimera.”
pSivida is independently developing a treatment for posterior uveitis that uses the same insert as Iluvien.
pSivida shares were trading 2.61% higher at $2.75 as of around 1 pm on Wednesday.
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