A new intravitreal corticosteroid implant for diabetic macular oedema (DME) has withstood complex regulatory processes to secure approval in Australia.
The Therapeutic Goods Administration (TGA) last week granted clearance for a treatment called Iluvien, which delivers 0.19mg fluocinolone acetonide via a sustained release implant that is effective for up to three years.
Independent, Melbourne-based biopharmaceutical company Specialised Therapeutics will supply the therapy in Australia. The company has signed an exclusive license with US-based Alimera Sciences, which commercialises and develops prescription ophthalmic pharmaceuticals.
The treatment has previously obtained approvals in other key healthcare markets including, Europe, Canada and the US, where it was first approved five years ago. In Australia, it will be available to patients with vision impairment associated with chronic DME that have been treated previously with corticosteroids and not experienced a clinically significant rise in intraocular pressure.
Iluvien is Specialised Therapeutics’ first candidate for the ophthalmic market, and CEO Mr Carlo Montagner said the company is in discussions with additional international drug developers to introduce therapies to the local market for other ocular diseases.
Iluvien’s main competitor is Allegan’s biodegradable intravitreal implant Ozurdex (dexamethasone 700 microgram), which is listed on the Pharmaceutical Benefits Sche (PBS) for DME. Montagner said Specialised Therapeutics would also seek to have Iluvien reimbursed for patients via the PBS, stating Iluvien was effective for longer.
“Our proposition to the PBS would be that the efficacy of Iluvien is comparable, if not better, than Ozurdex, so we would be seeking to be listed beside Ozurdex as an option for ophthalmologists,” he said, adding that the PBS listing process could take between 12 and 18 months.
Montagner said Iluvien was required to navigate a complex TGA process, which included heavy demands on donstrating its safety profile.
“There really is no question around the efficacy of Iluvien, but safety obviously is important because it is an implant that sits in the back of the year for up to three years,” he said.
“So we were put through the griller from a safety point of view and had to provide a substantial amount of evidence; probably more than what was required by the US Food and Drug Administration and the European Medicines Agency, and we did that, and ultimately we got it approved.”
Adopting a continuous microdosing delivery mechanism, the Iluvien implant is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid.
According to its developers, the treatment had demonstrated the ability to reduce oedema in the retina for up to 36 months. This enables the physician to treat eye disease daily, while ensuring patients maintain vision for longer with fewer injections.
