The FDA issued marketing approval to Anika Therapeutics Inc. for its Monovisc, a single-injection supplement to synovial fluid of the osteoarthritic joint.
Used to treat pain and improve joint mobility in patients with osteoarthritis (OA) of the knee, Monovisc is comprised of a sterile, clear, biocompatible, resorbable, viscoelastic fluid composed of partially crosslinked sodium hyaluronate in phosphate buffered saline. According to a company press release, it is indicated for the treatment of pain in OA of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics. Currently sold in Canada, the United Kingdom and several countries in the Middle East, Europe and Asia, the OA treatment will be marketed in the United States by DePuy Synthes, Mitek Sports Medicine.
“The U.S. market for viscosupplementation therapy is experiencing double digit growth annually. With FDA approval of Monovisc, we can be better positioned with our single- and multi-injection products to meet the varying needs of physicians and patients,” Charles H. Sherwood, PhD, president and chief executive officer of Anika Therapeutics, stated in the release. “We are moving forward rapidly with Mitek Sports Medicine to capitalize on the strengths of our viscosupplementation portfolio.”
