Anika Therapeutics Completes Enrollment in MONOVISC Pivotal U.S. Clinical Trial
Anika Therapeutics, Inc. announced that it has completed enrollment for its pivotal U.S. clinical trial for MONOVISC(TM). 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 U.S. and Canada for the study, which includes a six-month follow-up period. The Company expects to commence commercialization in the United States in 2010.
"Completing the enrollment of the U.S. trial for MONOVISC brings us closer to the domestic commercialization of our single-injection osteoarthritis product," said Charles H. Sherwood, Ph.D., Anika's president and chief executive officer. "MONOVISC is being very well received in Europe, where we launched the product in May. 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."
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