Knight Therapeutics Inc. (TSX: GUD) (“Knight”), a leading Canadian specialty pharmaceutical company, and SIFI S.p.A. (“SIFI”), a prominent Italian Eye Care company, today announced that Health Canada has approved NETILDEX® for the treatment of inflammatory ocular conditions of the anterior segment of the eye following cataract surgery where adjunct topical therapy to reduce the risk of bacterial infection is appropriate. Knight and SIFI entered into an exclusive Canadian agreement NETILDEX® in August 2016.
“We are excited about the approval of NETILDEX® in Canada, providing patients with a new antibiotic with a well-established corticosteroid” said Jonathan Ross Goodman, Chief Executive Officer of Knight.
“We are thrilled with the Canadian approval for NETILDEX®,” said Mr. Fabrizio Chines, Chairman and Chief Executive Officer of SIFI. “This approval will broaden the global availability of NETILDEX®, providing access to Canadian patients and physicians to our differentiated product.”
NETILDEX® is a fixed combination of netilmicin and dexamethasone indicated for the treatment of ocular inflammation of the anterior segment of the eye, in presence or at risk of bacterial infection. NETILDEX® has been successfully launched in Italy, Romania, Turkey, Mexico and Lebanon. Filing for regulatory approval in additional countries is ongoing. NETILDEX® is the first fixed combination product line available in single and multi-dose solution or single-dose hydrogel formulation. NETILDEX® has been tested in over 600 patients in multiple Phase III studies and has been shown to be safe and effective in each clinical study.