pSivida partner launches Iluvien in the UK

pSivida (ASX:PVA) licensee Alimera Sciences has launched diabetic macular edema (DME) treatment Iluvien in the UK market.

The sustained release drug delivery system is now available for privately insured patients in the UK, and Alimera has applied to have the product provided through the National Health Service in England and Wales.

Alimera has submitted the application to the National Institute for Health and Care Excellence (NICE) under the body’s Patient Access Scheme (PAS).

NICE has already knocked back two separate applications for reimbursement of Iluvien, stating that its reported benefits do not justify the price. But the PAS application is designed to address these cost concerns by showing that Iluvien is a good option for difficult-to-treat patients.

pSvida CEO Dr Paul Ashton said the launch “marks the first availability [in the UK] of a sustained release therapy for patients who suffer from DME and who have not responded to conventional therapies”.

pSivida designed the sustained release intravitreal implant used in Iluvien. It is designed to be injected into the back of the eye. There it delivers sustained submicrogram levels of fluocinolone acetonide over a period of up to 36 months.

Alimera has so far secured approval for Iluvien in the UK, Austria, Portugal, France, Spain and Germany. But the company has so far had difficulty securing approval in the US. The company recently resubmitted its application to the US FDA after an initial knockback. pSivida will be entitled to a US$25 million ($24.1 million) milestone payment if Iluvien is approved in the US.

pSivida is separately in clinical trials for a treatment for posterior uveitis using the same implant found in Iluvien.

pSivida shares were trading 5.66% lower at $2 as of around 2 pm on Tuesday.