Specialised Therapeutics Australia will seek a PBS listing for ILUVIEN (fluocinolone acetonide intravitreal implant) after confirming TGA approval of its implant for diabetic macular oedema.
ILUVIEN, which is a sustained release implant delivered by intra-ocular injection, has been approved for people who have vision impairment associated with chronic diabetic macular oedema (DME), and who have been previously treated with a course of corticosteroids and who have not experienced a clinically significant rise in intra-ocular pressure (IOP).
Specialised Therapeutics Australia is commercialising ILUVIEN in Australia under an agreement with US-based Alimera Sciences.
CEO Carlo Montagner said ILUVIEN is the company’s first ophthalmology therapy
“We are delighted to make this important new therapy available to Australian patients affected by DME, after successfully navigating what has been a complex regulatory process,” he said. “Our commercial teams will now work to ensure that all appropriate patients can access this therapy at the earliest opportunity."
DME is a primary cause of vision loss associated with diabetic retinopathy. The disease affects the macula, which is the part of the retina responsible for central vision. Diabetic retinopathy causes swelling in the macula due to blood vessel leakage, which leads to DME. Onset of the condition is painless and may go undetected until it manifests as blurred central vision or vision loss.
According to Alimera president and CEO Rick Eiswirth, “We are thrilled that ILUVIEN can now be accessed by Australian patients, following on from its approval in other key healthcare markets, including the United States, Europe and Canada.”