STA to distribute Iluvien in A/NZ

Specialised Therapeutics Australia (STA) has secured distribution rights in Australia and New Zealand for Iluvien, a treatment for diabetic macular oedema, from Alimera Sciences.

Iluvien is an intravitreal corticosteroid implant for treating vision loss associated with diabetic macular oedema. STA will take responsibility for all regulatory and commercial activities for the drug in the two markets.

As part of the deal, STA will pay Alimera a milestone payment upon achieving PBS listing, as well as ongoing royalty payments that will increase based on sales targets.

Because Iluvien uses a back-of-the-eye implant designed by pSivida (ASX:PVA), the company will be entitled to 20% of these royalties, and to 33% of the milestone payment.

STA CEO Carlo Montagner said that, while Iluvien is not yet approved for sale in Australia and New Zealand, it will be made available under the Special Access Scheme until the TGA and Medsafe approve the product.

“We look forward to Iluvien providing benefit to thousands of diabetic patients who suffer vision impairment as a result of type 1 or type 2 diabetes,” he said.

Iluvien implants are designed to provide sustained release of corticosteroid fluocinolone acetonide at sub-microgram levels for up to 36 months. Professor Mark Gillies, from the Department of Clinical Ophthalmology and Eye Health at the University of Sydney, said that in comparison some drugs that are currently injected in the eye only last four weeks.

“While there may be some side effects of Iluvien, these are treatable and a large clinical trial has demonstrated that many patients with advanced retinal disease will experience sustained improvement in their vision after receiving the implant,” he said.

pSivida (ASX:PVA) shares were trading unchanged at $4.00 as of around 1 pm on Tuesday