pSivida partner to resubmit Iluvien NDA this month

pSivida’s marketing partner Alimera plans to resubmit a New Drug Application for eye drug insert Iluvien with the US FDA by the end of March.

Alimera has advised that the new application will focus on the safety profile of Iluvien as a treatment for chronic diabetic macular edema (DME).

It will also concentrate on the population of patients with DME who do not respond satisfactorily to currently available treatments. Iluvien is already approved for sale to this cohort in various European countries.

pSivida said that if the NDA is approved, it will be entitled to a US$25 million ($23.9 million) milestone payment, as well as a 20% cut of the net profit from US sales.

Iluvien is an intravitreal insert developed by pSivida. The product provides sustained release doses of corticosteroid fluocinolone acetonide to treat chronic DME.

The FDA knocked back Alimera’s initial application for Iluvien in November 2011, requesting that the company conduct two more trials to demonstrate safety and efficacy.

The product by contrast has marketing approval in the UK, Austria, Portugal, France, Germany and Spain. Alimera has now advised it expects to begin shipping Iluvien to Germany in the second quarter once it has regulatory approval for the proposed batch size.

In the UK, Iluvien has been denied reimbursement from the National Institute for Health and Clinical Excellence (NICE) on the grounds that it is not cost-effective compared to competing treatments.

But the Department of Health has now agreed to a patient access scheme (PAS) and Alimera expects NICE to assess whether this scheme affects the cost-effectiveness enough to change this verdict.

pSivida is currently developing a treatment for posterior uveitis with the same insert used for Iluvien. The company has FDA approval for two inserts to treat other chronic eye diseases.

pSivida shares were trading 0.25% lower at $1.995 as of around 1.30 pm on Monday.