pSivida receives FDA approval for ILUVIEN

THE ROADHOUSE PHARMACY: pSivida Corp. (ASX: PVA) announced the United States Food and Drug Administration (FDA) has approved the company’s ILUVIEN® for the treatment of diabetic macular edema (DME).

pSivida specialises in the development of sustained release, drug delivery products for treating eye diseases.

The treatment has been indicated for patients who have been previously treated with a course of corticosteroids and did not have a clinical rise in intraocular pressure (IOP).

pSivida claimed a single injection of the ILUVIEN micro-insert provides sustained treatment of DME for 36 months.

Approximately 560,000 people in the US are estimated to have clinical DME, the most frequent cause of vision loss in individuals with diabetes and the leading cause of blindness in young and middle-aged adults in developed countries.

pSivida anticipates ILUVIEN to be commercially available in the US in early 2015.

Achieving FDA approval of ILUVIEN entitles pSivida to a $25 million milestone from its licensee Alimera Sciences.

The company will also be entitled to 20 per cent of the net profits from sales of ILUVIEN in the US.

“FDA approval of ILUVIEN, our third FDA-approved product for retinal disease, provides an important treatment option for DME patients in the US, the majority of whose DME, despite anti-VEGF intra-ocular injections as frequently as monthly, is not optimally managed,” pSivida president and chief executive officer Dr Paul Ashton said in the company’s announcement to the Australian Securities Exchange.

“ILUVIEN’s clinical trials showed that ILUVIEN can actually reverse vision loss in many DME patients.

“Another advantage of ILUVIEN over existing therapies is that a single injection provides sustained therapy for three years.

“The $25 million milestone will help finance our ongoing product development program, including Medidur™ for posterior uveitis and Tethadur™ for the sustained delivery of biologics.”

pSivida is independently developing Medidur, an injectable, sustained release micro-insert of the same design and delivering the same drug as ILUVIEN, for the treatment of chronic posterior uveitis, the third largest cause of blindness in the US.

The company plans to seek FDA approval of this product on the basis of its ongoing single Phase III clinical trial.

Enrollment of this study is expected to be completed by the end of the first quarter of calendar 2015.

ILUVIEN is already commercially available in the United Kingdom and Germany, and has received or is pending marketing approval in seventeen other EU countries, for the treatment of patients with the chronic DME insufficiently responsive to available therapies.

“We are very pleased that the FDA’s approval of ILUVIEN is not limited, as in the EU, to the subset of patients with chronic DME, patients who have failed other therapies, or patients who have had cataract surgery,” Dr Ashton continued.

pSivida explained ILUVIEN is an injectable micro-insert that provides sustained treatment through continuous delivery of a submicrogram dose of the corticosteroid fluocinolone acetonide for 36 months.

Current standard-of-care therapy requires anti-VEGF injections into the eye as frequently as monthly, and studies show that over 50 percent of patients are not optimally managed with this treatment.

pSivida  said the FDA approval was based on clinical trial data that showed that at month 24, 28.7 percent of patients receiving ILUVIEN experienced an improvement from baseline in their best corrected visual acuity on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart of 15 letters or more.

This improvement in vision was maintained through 36 months, the end of the trials.

Website: www.psivida.com