ORTHOVISC®

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    Hyaluronic Acid Comparison

    Compare ORTHOVISC® to other viscosupplements of the knee:

    • ORTHOVISC® is a non-avian, bacterial sourced HA
    • Up to 6-months durability of symptom relief with just 3 injections1
    • Highest HA concentration among viscosupplements
    • Statistically and clinically significant symptom improvement1
    • No Pseudoseptic reaction reportedPseudoseptic reaction reported
      Severe inflammation of the joint often with significant pain normally occurring 24 to 72 hours after intraarticular injection; often requires clinical intervention       in more than 1 million injections2

     

    COMPARISON OF VISCOSUPPLEMENTS

    Information from product labeling

    COMPARISON OF VISCOSUPPLEMENTS

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    This site is published by DePuy Mitek, Inc., which is solely responsible for its contents.
    It is intended for healthcare professionals in the U.S. and contains U.S. based product information only.
    ORTHOVISC® is manufactured by and is a registered trademark of Anika Therapeutics, Inc. Distributed by DePuy Mitek, Inc.

    © DePuy Mitek, Inc. 2005 - 2012

    Important Safety Information

    ORTHOVISC® is indicated in the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g. acetaminophen. In clinical studies, the most commonly reported adverse events were arthralgia, back pain, and headache. Other side effects included local injection site adverse events.

    ORTHOVISC® is contraindicated in patients with known hypersensitivity to hyaluronate formulations or known hypersensitivity (allergy) to gram positive bacterial proteins. ORTHOVISC® should not be injected in patients with infections or skin diseases in the area of the injection site or joint. Strict aseptic technique should be used. The effectiveness of more than 1 course has not been established.

    REFERENCES

    1. Brandt KD, et al. Efficacy and Safety of Intraarticular Sodium Hyaluronate in Knee Osteoarthritis. Clin Orthop. 2001;385:130-143.
    2. MedLine and FDA Maude/MDR database searches, October 2008
    bORTHOVISC® Package Insert—An integrated safety analysis was onducted, pooling ORTHOVISC groups from the 3 studies (n=562) and pooling the control groups, which were either intra-articular saline injections (n=296) or arthrocentesis (n=123). Study to demonstrate safety of ORTHOVISC retreatment, OAK0101, shows comparable adverse events in retreatment versus first treatment course.
    c,d,eEuflexxaTM Package Insert—Multicenter clinical investigation study was conducted at 10 sites in Germany. A total of 160 patients received 478 injections of Euflexxa resulting in joint swelling 1.9% and joint effusion 0.6%. Single-center clinical investigation was conducted in Israel and showed treatment-related adverse events (n=34) were knee pain 29.4% and knee swelling 2.9%.
    fSupartz® Package Insert—An evaluation of the safety population included all patients receiving at least one injection (n=619 Supartz and n=537 control) in five controlled clinical trials. Two adverse events reported at the injection site were injection site pain 4.2% and injection site reaction 5.7%.
    gPain relief did not demonstrate statistical significance vs. control.
    hIncludes application/injection site reaction, injection site inflammation, and purpura injection site.
    iHyalgan® Package Insert—A clinical investigation in the United States in which there were three arms (n=164 Hyalgan, n=168 placebo, and n=163 naproxen). A statistically significant difference in the occurrence of pain at the injection site was noted in the Hyalgan-treated subjects (23%) in comparison with placebo-treated subjects (13%) and knee pain and swelling was noted at (13%).
    jSynvisc® Package Insert—A total of 511 patients (559 knees) received 1771 injections in seven clinical trials of Synvisc. There were 39 reports in 37 patients (2.2% of injections, 7.2% of patients) of knee pain and/or swelling. A total of 157 patients received 553 injections in the three clinical trials of repeated courses of Synvisc treatment. Forty-eight reports of adverse events localized to the injected knee in 35 patients accounted for 6.3% of injections in 22.3% of patients.

    Synvisc® is a registered trademark of Genzyme Corporation.
    Hyalgan® is a registered trademark of sanofi-synthelabo.
    Supartz® is a registered trademark of Seikagaku Corporation.
    Euflexxa™ is a trademark of Ferring Pharmaceuticals, Inc.