Alimera Sciences (NSDQ:ALIM) and Knight Therapeutics (TSE:GUD) said today that Health Canada accepted the companies’ New Drug Application for its intravitreal implant, Iluvien.
The FDA approved Atlanta-based Alimera’s sustained release intravitreal implant in 2014 to treat diabetic macular edema in patients who have been previously treated with corticosteroids and did not have a clinically significant rise in intraocular pressure.
Healthcare practitioners use an applicator with a 25-gauge needle to inject the Iluvien intravitreal implant into the back of the patient’s eye. Each implant is designed to release microdoses of the corticosteroid flucinolone acetonide for 36 months.
“This is another important milestone for Iluvien,” Alimera CEO Dan Myers said in prepared remarks. “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.”
pSivida (NSDQ:PSDV) licensed Iluvien to Alimera in 2008 and in July 2015, Knight and Alimera inked a deal granting Knight the exclusive distribution rights for Iluvien in Canada.
“Iluvien is a unique and innovative product that is available in different markets around the world, including the U.S. and Europe,” Knight CEO Jonathan Ross Goodman added. “We are happy to continue advancing Iluvien and our portfolio of novel therapeutics that improve the health of Canadian patients.”
ALIM shares were trading at $1.29 apiece in mid-morning activity, up 3.2%.