About Osteoarthritis (OA) of the Knee
Greater than 5% of the world's population is afflicted by osteoarthritis of the knee, making it the most common joint disease. Most commonly affecting middle-aged and older people, OA can range from very mild to very severe. Risk factors include being overweight, joint injury, muscle weakness, having other forms of arthritis and heredity. Approximately 10 million Americans currently suffer from OA of the knee and that number is expected to increase.
OA of the knee is characterized by the breakdown of cartilage, the part of the joint that cushions the ends of bones, causing bones to rub against each other, resulting in pain and loss of movement. Degradation changes in the synovial fluid contained in the joint may also play a role in OA. Synovial fluid, which mostly consists of hyaluronan, lubricates the joint and is needed to facilitate movement of the joint.

Standard treatment modalities that seek to relieve pain, improve mobility and increase range of motion include analgesics, nonsteroidal anti-inflammatory drug (NSAIDS), viscosupplementation and intra-articular steroids. Should these approaches become insufficient or fail, some patients may become surgical candidates. Viscosupplementation represents an effective, safe, convenient and non-surgical therapeutic alternative or adjunct to physical therapy, medication or surgery.

Product Summary

Orthovisc

OrthoVisc is indicated for the treatment of pain in OA of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics, such as acetaminophen. It is a sterile, non-pyrogenic, clear, viscoelastic solution of hyaluronan contained in a single-use syringe. OrthoVisc consists of high molecular weight, ultra-pure natural hyaluronan dissolved in physiological saline. A natural complex sugar of the glycosaminoglycan family, hyaluronan is a high molecular weight polysaccharide composed of repeating disaccharide units of sodium glucuronate and N-acetylglucosamine. The hyaluronan is extracted from rooster combs. OrthoVisc is injected into the knee joint in a series of intra-articular injections one week apart.

The FDA approval of OrthoVisc is based on integrated effectiveness data from two randomized, controlled, double-blind multi-center Phase III U.S. clinical studies encompassing a total of 458 patients suffering from OA of the knee. Safety data from a third U.S. trial were also included in the FDA review.

The objective of the studies was to assess the effectiveness of OrthoVisc for the treatment of joint pain. Patients were divided into three and four OrthoVisc injection regimen groups and two control groups: arthrocentesis and saline injection. Patients were evaluated for improvement in pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at four follow-up assessments over weeks 7 through 22 of the studies. The primary effectiveness analysis compared the proportion of OrthoVisc patients achieving a greater improvement from baseline in WOMAC pain score versus controls. Patients in both groups experienced a statistically significant improvement as measured by change in WOMAC pain scores. An integrated safety analysis, which included 562 patients treated with OrthoVisc, had an extremely low rate of adverse events. There were no serious adverse events associated with OrthoVisc.

Orthovisc mini

Orthovisc mini is approved only in the European Economic Area. For more information about this product please visit orthoviscmini.com

Monovisc

Monovisc is approved only in the European Economic Area. For more information about this product please visit monovisc.com



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