Alimera Sciences and Knight Therapeutics, a Canadian specialty pharmaceutical company, announced that Knight's New Drug Submission (NDS) for Iluvien has been accepted for review by Health Canada. Iluvien (fluocinolone acetonide intravitreal implant) 0.19 mg is Alimera's sustained release intravitreal implant approved in the US to treat 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 intraocular pressure.
"Iluvien is a unique and innovative product that is available in different markets around the world, including the US and Europe," Jonathan Ross Goodman, CEO of Knight, said in a company news release. "We are happy to continue advancing Iluvien and our portfolio of novel therapeutics that improve the health of Canadian patients."
"This is another important milestone for Iluvien," Dan Myers, CEO of Alimera, said in the news release. "We believe Iluvien is the only therapy that treats DME consistently every day due to its continuous microdosing for up to 3 years, and we look forward to working with Knight and Health Canada to make Iluvien available to Canadian patients."
Knight and Alimera signed an agreement in July 2015 granting Knight the exclusive right to distribute Iluvien in Canada.