Alimera Announces Iluvien Regulatory Approval in Australia for the Treatment of DME

Alimera Sciences announced that the Australian Therapeutic Goods Administration (TGA), the division of the Australian Department of Health that oversees the availability of medical products, has approved Iluvien (190 micrograms intravitreal implant in applicator) for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in IOP.

Iluvien will be commercialized throughout Australia by Specialised Therapeutics under exclusive license from Alimera Sciences. 

“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,” Carlo Montagner, CEO of Specialised Therapeutics, said in a company news release. “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.”

“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,” said Rick Eiswirth, president and CEO of Alimera. “We are proud to collaborate with Specialised Therapeutics and to make Iluvien available to patients in Australia who are suffering from DME and would like the opportunity to see better, longer with fewer injections.”