pSivida partner gets new PDUFA date for Iluvien
pSivida (ASX:PVA) and licensee Alimera Sciences have revealed that the US FDA will decide by mid-October whether to approve intravitreal insert Iluvien for diabetic macular edema (DME).
The FDA has accepted Alimera’s resubmitted New Drug Application (NDA) for Alimera and declared it a complete response, the companies announced.
The agency has now set a new PDUFA date - the deadline for it to approve NDAs - of 17 October. pSivida will be entitled to a US$25 million milestone payment if and when Iluvien is approved in the US.
Alimera’s initial application to the FDA in 2011 was met with a complete response letter demanding more information on the safety and efficacy of the implant.
The company resubmitted its NDA in late March, providing additional analysis and information on the safety and efficacy of Iluvien in the subgroup of patients with chronic DME.
Alimera has secured approval for Iluvien in this subgroup of patients in six countries in the EU. This week, the company launched the product in the UK for private health insurance customers.
pSivida is in clinical trials for a treatment for posterior uveitis that uses the same implant as Iluvien.
pSivida shares were trading unchanged at $2.03 as of around 2.30 pm on Thursday.
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