pSivida’s treatment for chronic diabetic macular edema awaits FDA approval
pSivida Corp (ASX: PVA) has announced that its licensee, Alimera Sciences, has resubmitted its response to the US Food and Drug Administration (FDA) with respect to Iluvien for chronic diabetic macular edema.
Alimera submitted the response, which includes additional analyses of the risks and benefits of Iluvien based on clinical data available from previously completed phase III studies, following a meeting with the FDA in the second quarter 2012.
The resubmission focuses on the safety aspects of Iluvien and patients with chronic diabetic macular edema. Marketing approval of Iluvien for this group of patients has been granted in six EU countries to date.
A specialty pharmaceutical company, pSivida develops sustained-release drug delivery products designed to deliver drugs at a controlled and steady rate for months or years. The company is currently focusing on sustained-release opththalmic treatments.
If the FDA approves Iluvien, pSivida would be entitled to a $25 million milestone payment, as well as 20% of net profits, on sales made by Alimera in the US.
pSivida shares were trading at $2.22 at around 11 am on Tuesday.
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