Patients in Australia with diabetes-induced eye disease now have a new treatment option.
The Australian Therapeutic Goods Administration (TGS) has approved the drug ILUVIEN® (fluocinolone acetonide intravitreal implant).
The drug is delivered via a sustained release implant and provides a therapeutic effect for up to 36 months, according to a company press release.
It is available to 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.
ILUVIEN will be supplied throughout Australia by independent biopharmaceutical company Specialised Therapeutics, under exclusive license from US-based Alimera Sciences, Inc.
“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,” said Carlo Montagner, CEO of Specialised Therapeutics. “Our commercial teams will now work to ensure that all appropriate patients can access this therapy at the earliest opportunity.”
What is Diabetic Macular Oedema?
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.
The onset of the condition is painless and may go undetected until it manifests as blurred central vision or vision loss.
“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,” said Rick Eiswirth, Alimera President and CEO.
Additional information can be found at www.stbiopharma.com.
- Alimera Sciences Inc., (2019, August 5). Alimera Announces ILUVIEN® Regulatory Approval in Australia for the Treatment of Diabetic Macular Edema. Retrieved August 5, 2019, from https://www.globenewswire.com/news-release/2019/08/05/1896809/0/en/Alimera-Announces-ILUVIEN-Regulatory-Approval-in-Australia-for-the-Treatment-of-Diabetic-Macular-Edema.html