The Iluvien implant has received regulatory approval from the Australian Therapeutic Goods Administration for the treatment of diabetic macular edema, Alimera Sciences announced.
Iluvien (fluocinolone acetonide intravitreal implant 0.19 mg) is approved in DME patients who have previously been treated with corticosteroids and did not have a clinically significant rise in intraocular pressure, according to a company press release.
“With this approval, we continue to execute on our strategy to grow Iluvien sales in existing markets and introduce the product in new territories to maximize the value of this differentiated therapy,” Rick Eiswirth, president and CEO of Alimera, said.
Specialised Therapeutics will commercialize Iluvien in Australia under an exclusive license from Alimera.
“We are delighted to make this important new therapy available to Australian patients affected by DME following the successful navigation of a complex regulatory process,” said Carlo Montagner, CEO of Specialised Therapeutics. “Our commercial teams will now work to ensure that all appropriate patients will have access to this therapy at the earliest opportunity as we now seek Iluvien reimbursement through the Australian Pharmaceutical Benefits Scheme.”