The study is designed to demonstrate that the single-injection Monovisc safely provides symptomatic relief of knee pain and associated dysfunction in patients with osteoarthritis. Anika plans to enroll approximately 350 patients at up to 20 sites in the US and Canada.
Charles Sherwood, Anika’s president and CEO, said: “The initiation of this study is a key step toward commercialization of our Monovisc product in the US. Monovisc leverages our new technology platform using a cross-linked, non-animal source of hyaluronic acid, delivered in an easy-to-use, single injection format. Administering this solution through a single injection can offer a convenient option for doctors and patients.”