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news.Anika Therapeutics, a developer of therapeutic products for tissue protection, healing and repair, has completed enrollment for its pivotal US clinical trial for Monovisc, a next-generation hyaluronic acid-based therapy for treating osteoarthritis.
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The randomized, double-blind, controlled study is designed to demonstrate that the single-injection Monovisc safely provides symptomatic relief of knee pain in patients with osteoarthritis.
Anika enrolled approximately 350 patients at sites in the US and Canada for the study, which includes a six-month follow-up period. The company expects to commence commercialization in the US in 2010.
Charles Sherwood, president and CEO of Anika, said: “Completing the enrollment of the US trial for Monovisc brings us closer to the domestic commercialization of our single-injection osteoarthritis product. Monovisc is being very well received in Europe, where we launched the product in May 2008.
“Coincident with that launch, we completed a post-approval study of Monovisc in Europe and the interim results on the product’s performance and duration of action are very strong.”