Health Canada Approves NETILDEX® Ophthalmic Solution
Knight Therapeutics and SIFI S.p.A. have received approval from Health Canada for NETILDEX®, an ophthalmic solution for inflammatory eye conditions. The approval expands the availability of the drug in Canada.
Knight Therapeutics Inc. and its partner SIFI S.p.A. have announced the approval of NETILDEX® by Health Canada. The ophthalmic solution is indicated for inflammatory ocular conditions of the anterior segment of the eye following cataract surgery where there is a risk or presence of bacterial infection.
The approval, granted by Canada's federal health department, follows an exclusive agreement made between Knight Therapeutics and SIFI in August 2016 for the commercialization of NETILDEX® in Canada. This regulatory milestone allows for broader patient access to the treatment within the Canadian market.
NETILDEX® is an ophthalmic combination product containing netilmicin, an antibiotic, and dexamethasone, a corticosteroid. It has been previously launched in several international markets including Italy, Romania, Turkey, Mexico, and Lebanon. The company indicated that filings for regulatory approval are ongoing in additional countries.
Knight Therapeutics specializes in acquiring and commercializing pharmaceutical products in Canada and select international markets. SIFI is an Italian ophthalmic company focused on eye care since 1935.