FDA Approves Monovisc Single-Injection Treatment for Knee OA Pain
Anika Therapeutics, Inc., has received FDA marketing approval for Monovisc, a single-injection supplement to synovial fluid of the osteoarthritic joint, used to treat pain and improve joint mobility in patients who have osteoarthritis (OA) of the knee.
Monovisc is indicated for the treatment of pain in knee OA in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics (e.g., acetaminophen). It is a sterile, nonpyrogenic, viscoelastic solution of hyaluronan (HA)—a complex sugar of the glycosaminoglycan family—contained in a single-use syringe. Monovisc was designed to deliver an HA dose comparable to Anika’s three-injection viscosupplement, Orthovisc, in a single 4 mL intra-articular injection.
The FDA approval of Monovisc is based on safety and effectiveness data from a randomized, controlled, double-blind, multicenter, pivotal U.S. clinical study of 369 patients with knee OA at 31 centers in the U.S. and Canada. The objective of the study was to assess the safety and effectiveness of Monovisc for the treatment of joint pain. Patients were randomized to either Monovisc or saline injection and were evaluated for improvement in pain, as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at follow-up assessments up to 26 weeks. The primary effectiveness analysis compared the proportion of Monovisc patients achieving a greater improvement from baseline in WOMAC pain score versus control through 12 weeks. The safety analysis showed that Monovisc had an extremely low rate of adverse events. There were no serious adverse events associated with Monovisc.
