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pSivida to resubmit ILUVIEN drug application to US regulators

pSivida to resubmit ILUVIEN drug application to US regulators

pSivida's (ASX:PVA) will be resubmitting a New Drug Application for its ILUVIEN drug treatment for chronic diabetic macular edema (DME) to US regulators by end of this month.

The submission to US Food and Drug Administration will be made by Alimera Sciences, pSivida's licensee.

The resubmission will focus on the safety aspects of ILUVIEN and the population of patients with chronic DME considered insufficiently responsive to available therapies, using data from Alimera’s two previously completed pivotal Phase III clinical trials.

This is the same group for which marketing approval for ILUVIEN has been granted in various EU countries.

Approval in the U.S. would entitle pSivida to a $25 million milestone payment from Alimera and 20% of net profits, from U.S. sales of ILUVIEN by Alimera.

Alimera is also likely to ship ILUVIEN to German markets in the second quarter of this year, while shipments to the UK for treatment of privately insured patients will also start in the same quarter.

Meanwhile, the UK's Department of Health has agreed to a submission of a patient access scheme (PAS) to ILUVIEN for DME and is now under consideration by NICE for inclusion in rapid review facility.

Alimera said that under the review facility, NICE is expected to assess the impact of the PAS on ILUVIEN’s cost effectiveness and determine whether an update to the final guidance is warranted.

pSivida is a specialty pharmaceutical company that develops sustained release ophthalmic drug treatments.

pSivida is currently focused on treatment of chronic diseases of the back of the eye utilizing its core technology systems, Durasert and BioSilicon.

The injectable, sustained release micro-insert ILUVIEN for the treatment of chronic Diabetic Macula Edema, licensed to Alimera has received marketing authorization in Austria, France, Germany, Portugal, the U.K. and Spain and is awaiting authorization in Italy.


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