Anika Therapeutics, Inc (BEDFORD, Massachusetts), focused on chemically modified hyaluronic acid (HA) therapeutic devices designed to repair, protect, and heal bone, cartilage, and soft tissue, announced that it has enrolled the first patient in a multicenter pivotal study evaluating its single-injection osteoarthritis (OA) product, Monoviscâ„¢. The randomized, double-blind, controlled study is designed to demonstrate that the device safely provides symptomatic relief of knee pain and associated dysfunction in patients with OA. Anika plans to enroll ~350 patients at up to 20 sites in the US and Canada. Monovisc utilizes a cross-linked, nonanimal source of HA, delivered in a single-injection format. The product received European CE Mark approval in September 2007 and expects to launch in Europe in the first half of 2008.

Anika's products include Orthovisc®, a treatment for OA of the knee available internationally and marketed in the US by DePuy Mitek, Inc, a subsidiary of Johnson & Johnson. Orthovisc 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, such as acetaminophen. It is a sterile, nonpyrogenic, clear, viscoelastic solution of hyaluronan contained in a single-use syringe. The drug consists of high molecular weight, ultra-pure, natural hyaluronan that is extracted from rooster combs and dissolved in physiological saline. A natural complex sugar of the glycosaminoglycan family, hyaluronan is a high molecular weight polysaccharide of repeating disaccharide units of sodium glucuronate and N-acetylglucosamine.

Orthovisc is administered as one intra-articular injection for 3 consecutive weeks and can relieve knee pain for up to 6 months. The US FDA approval of Orthovisc was based on integrated effectiveness data from two randomized, controlled, double-blind multicenter phase III US clinical studies that enrolled 458 patients suffering from OA of the knee. Safety data from a third US trial were also included in the FDA review.