The study is designed to determine whether Agilus is superior to saline-control in reducing the debilitating pain associated with ankle osteoarthritis (ankle OA). If Agilus is proven to be safe and effective, it could provide a new option for people with ankle OA for whom current therapies are inadequate or who want to delay or potentially avoid surgery.
Carticept expects to enroll 380 patients at 20 sites throughout the US. The first patients were treated at Pinnacle Research in Royal Palm Beach, Florida and the Orthopedic Foot and Ankle Center in Columbus, Ohio.
Timothy Patrick, president and CEO of Carticept, said: “Viscosupplementation therapies have been available for years to treat pain in the larger joints but, unlike these earlier treatments, Agilus was specifically designed to optimize performance in mid-size and small joints. We believe its formulation is ideal not only for the ankle, but potentially for other joints in the foot and hand.”