What Is Monovisc?

Viscosupplement for Knee Osteoarthritis

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Monovisc is a single injection viscosupplement used to treat knee joints affected by osteoarthritis. It is an intra-articular injection, meaning, it is injected into the affected joint. Monovisc was developed by Anika Therapeutics, Inc. and received marketing approval from the U.S. FDA on February 25, 2014. Monovisc is marketed by DePuy Synthes, Mitek Sports Medicine under a license agreement with Anika.

The hyaluronan (a complex sugar of the glycosaminoglycan family) in Monovisc is a  high molecular weight, ultra pure derivative of natural hyaluronan from a non-animal source. The hyaluronan is derived from bacterial cells and is cross-linked with a proprietary solution. Monovisc delivers a comparable dose to Orthovisc, another Anika Therapeutics viscosupplement -- but Orthovisc is administered in a series of three injections rather than a single injection.

Indications

Monovisc is indicated for the treatment of knee osteoarthritis in patients who have failed conservative treatments, such as non-drug treatments and non-narcotic pain medications (e.g., acetaminophen). The primary characteristic of knee osteoarthritis is cartilage damage which causes considerable pain and limited range of motion in the affected joint. In osteoarthritis, there are abnormalities with the synovial fluid as well.

Synovial fluid lubricates the joint normally, allowing for friction-free movement. Viscosupplements, such as Monovisc and others that were previously approved, return viscous, lubricating properties to the joint.  

Study Results

Safety and effectiveness data from a randomized, controlled, double-blind clinical study involving 369 study participants with knee osteoarthritis at 31 centers in the U.S. and Canada was the basis for the FDA approval of Monovisc, according to Anika Therapeutics.

The participants were randomly assigned Monovisc or saline injections (the control). They were evaluated for improvement in joint pain using WOMAC (the Western Ontario and McMaster Universities Osteoarthritis Index), specifically looking for Monovisc patients who achieved a greater improvement in their WOMAC score compared to control patients over a 12-week period. The safety portion of the analysis revealed an "extremely low rate of adverse events" and no serious adverse events with Monovisc. 

Other Viscosupplements

The first viscosupplement was approved in 1997. There are now 5 other viscosupplements, most of which require a series of injections rather than a single injection.

Effectiveness of Viscosupplementation

In 2012, a report published in the Annals of Internal Medicine concluded that viscosupplementation was ineffective and risky. The report stated that viscosupplementation produces an irrelevant reduction in pain while potentially increasing the risk of flare-ups and adverse events.

This conclusion was based on a meta-analysis of 89 randomized trials involving more than 12,000 knee osteoarthritis patients. 

The American Academy of Orthopaedic Surgeons, however, states that "Viscosupplementation can be helpful for people whose arthritis has not responded to basic treatments. It is most effective if the arthritis is in its early stages (mild to moderate). Some patients may feel pain at the injection site, and occasionally the injections result in increased swelling. It may take several weeks to notice an improvement after viscosupplementation. Not all patients will have relief of pain. If the injections are effective they may be repeated after a period of time, usually 6 months. The long-term effectiveness of viscosupplementation is not yet known and research continues in this area."

Sources:

FDA Approves Monovisc, A New Single Injection Treatment for Treatment of Pain Due to Osteoarthritis of the Knee. Anika Therapeutics. February 25, 2014.
http://ir.anikatherapeutics.com/releasedetail.cfm?ReleaseID=828235

Viscosupplementation for Osteoarthritis of the Knee: A Systematic Review and Meta-analysis. August 7, 2012. Rutjes et al. Annals of Internal Medicine.
http://annals.org/article.aspx?articleid=1305531&resultClick=3

Viscosupplementation Treatment for Arthritis. OrthoInfo. AAOS. April 2013.
http://orthoinfo.aaos.org/topic.cfm?topic=a00217

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