VISCO-3™ Sodium Hyaluronate

VISCO-3 Sodium Hyaluronate is a solution made of highly purified, hyaluronan. You will administer to the patients, a 2.5 mL injection of VISCO-3 Sodium Hyaluronate once a week for 3 weeks (a total of 3 injections).  One clinical trial revealed patients treated with VISCO-3 Sodium Hyaluronate had a 52% reduction in their pain at week 12.1

Indications For Use
VISCO-3 Sodium Hyaluronate is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
Important Safety Information
Before using VISCO-3 Sodium Hyaluronate, ask your patients if they are allergic to hyaluronan products, or products from birds such as feathers, eggs, and poultry. Do not administer to patients with known hypersensitivity to sodium hyaluronate preparations. Use caution when injecting VISCO-3 Sodium Hyaluronate into patients who are allergic to avian proteins, feathers and egg products. VISCO-3 Sodium Hyaluronate is only for injection into the knee, performed by a doctor or other qualified health care professional. VISCO-3 Sodium Hyaluronate injection should not be used in the presence of a skin disease or infection around the area where the injection will be given. VISCO-3 Sodium Hyaluronate has not been tested to show pain relief in joints other than the knee and for conditions other than OA. VISCO-3 Sodium Hyaluronate has not been tested in patients who are pregnant, mothers who are nursing, or anyone under the age of 21. Strenuous or pro-longed weight-bearing activities after treatment are not recommended. The effectiveness of repeat treatment cycles of VISCO-3 Sodium Hyaluronate has not been established. The side effects most commonly seen after injection of VISCO-3 Sodium Hyaluronate in the clinical trial were knee pain, swelling, and/or fluid build-up around the knee. These reactions are generally mild and do not last long. Other conditions, including but not limited to skin redness and rash, knee stiffness were also reported. For complete instructions for use, see the package insert and visit www.zimmerbiomet.com.
This material is intended for US Health Care Professionals.

A double-blind, multi-center, randomized, controlled trial was conducted in which VISCO-3 Sodium Hyaluronate*was compared to Euflexxa® 1% Sodium Hyaluronate (NCT 02110238). The study enrolled a total of 421 subjects.1

 

Safety 2

Safety analysis included all subjects who received at least one injection (n = 211 Euflexxa, n = 209 VISCO-3). There was no significant difference in the total Treatment-Emergent Adverse Events (TEAEs) with VISCO-3 Sodium Hyaluronate compared to Euflexxa (Table 1). A total of seven serious adverse events (SAE) were reported, however none were considered to be related to the study devices. There were no reports of pseudoseptic events or allergic reactions in the study. The most common device related adverse events in the VISCO-3 group were arthralgia (1%), joint swelling (1.4%) and injection site pain (1%). 

Table 1: Overall Summary of Treatment-Emergent Adverse Events (TEAEs)

Category

Euflexxa (N=211) n(%)

VISCO-3 (N=209) n(%)

Subjects with ≥ 1 TEAE  

109 (51.7)

107 (51.2)

Subjects with ≥ 1 TEAE related to study device

14 (6.6)

9 (4.3)

Subjects with ≥ 1 serious adverse event (SAE)

6 (2.8)

1 (0.5)

 

Effectiveness2

The analysis of effectiveness was based on the 384 evaluable patients over the 12 week time point. The effectiveness of the treatments was measured as WOMAC VAS pain subscale change from base line (CFB). The Key effectiveness outcomes are presented below (Table 2). The mean baseline WOMAC VAS pain subscale was 57.83 in the VISCO-3 Sodium Hyaluronate group and 58.40 in the Euflexxa Sodium Hyaluronate group. The least squares mean for CFB for VISCO-3 Sodium Hyaluronate minus that of the control gives a WOMAC VAS subcale sore of -3.30 mm.

Table 2: Effectiveness Analysis; CFB of WOMAC VAS Pain Subscale Through Study Duration

Average over Weeks 3, 6, and 12

Euflexxa (N=189)

VISCO-3 (N=195)

CFB Difference

Baseline WOMAC VAS Pain (mm) (Mean[SD])

58.40

(8.977)

57.83

(9.654)

 

LS Mean (standard error [SE]) of change from Baseline (CFB)

30.15

(1.303)

26.85

(1.270)

-3.30 (1.762)

95% CI

27.59-32.71

24.35-29.35

-6.77-0.17

 

VISCO-3 Sodium Hyaluronate demonstrated noninferior pain relief compared to patients treated with Euflexxa Sodium Hylauronate. This is concluded based upon the fact that the lower bound of the 95% CI (-6.77 mm) is greater than -8 mm. On average, patients treated with VISCO-3 Sodium Hyaluronate saw a 52% reduction in pain at week 12 compared to baseline.

 

Post Market Experience2

Literature has shown that repeated treatment cycles of the VISCO-3 Sodium Hyaluronate formulation contain no evidence of an increased safety risk. The frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle. 

VISCO-3 is a sterile, viscoelastic non-pyrogenic solution of purified, high molecular weight (620,000-1,170,000 daltons) sodium hyaluronate (hyaluronan) having a pH of 6.8-7.8. Each one mL of VISCO-3 solution contains 10 mg of sodium hyaluronate (hyaluronan) dissolved in a physiological saline (1.0% solution). The sodium hyaluronate (hyaluronan) is extracted from chicken combs. Sodum hyaluronate (hyaluronan) is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine.

 

Each 2.5 mL prefilled syringe of VISCO-3 solution contains:

Sodium Hyaluronate (hyaluronan) 25.0 mg

Sodium Chloride 21.25 mg

Dibasic Sodium Phosphate Dodecahydrate 1.343 mg

Sodium Dihydrogen Phosphate Dihydrate 0.04 mg

Water for Injection q.s.

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Strict aseptic administration technique must be followed. Apply antiseptic to the skin and, if desired, local subcutaneous anesthetic such as lidocaine may be injected prior to injection with VISCO-3 Sodium Hyaluronate. Do not use disinfectants containing quaternary ammonium salts for skin preparation.

1000x1000_insetimage_Figure-2

The knee joint may be accessed through the soft palpable anterolateral port, located just lateral to the inferior pole of the patella and the proximal portion of the patella tendon (Figure 1) or other approach per physician preference.

If present, remove joint effusion before injecting VISCO-3 Sodium Hyaluronate (Figure 2).

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Peel off the lid from the VISCO-3 Sodium Hyaluronate blister package and remove the syringe. Carefully remove the tip cap of the VISCO-3 Sodium Hyaluronate syringe. Aseptically attach the VISCO-3 Sodium Hyaluronate syringe to a sterile 22-23 gauge needle.

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Inject the full 2.5 mL of VISCO-3 Sodium Hyaluronate into the knee joint using aseptic injection technique (Figures 3-4). If administering treatment to both knees, use a separate syringe of VISCO-3 Sodium Hyaluronate for each knee.

Administer the subsequent two intra-articular injections one week apart, for a total of three injections 1 week apart for 3 weeks.

VISCO-3 Sodium Hyaluronate is supplied as a sterile, non-pyrogenic solution in 2.5 mL prefilled syringe (1.0% solution[ 10 mg/mL] 25mg total sodium hyaluronate (hyaluronan). VISCO-3 Sodium Hyaluronate is administered by intra-articular injection once a week (1 week apart) for a total of 3 injections. 

Store in the original packaging below 77°F (25°C). DO NOT FREEZE.

DO NOT USE after expiration date indicated on package. VISCO-3 Sodium Hyaluronate has a shelf life of 42 months.

The prefilled syringe is intended for single use.

  • Use immediately once the container has been opened.
  • Discard any unused VISCO-3 Sodium Hyaluronate

DO NOT USE if the package is opened or damaged.

Questions regarding reimbursement may be addressed by contacting the Zimmer Biomet Reimbursement Hotline:

Phone: 1-866-946-0444

Email: reimbursement@zimmer.com

Zimmer Biomet Reimbursement Hotline Hours: Monday-Friday, 8am-5pm EST

Information and material about reimbursement is informational only.  Changes in reimbursement laws, regulations, and policies may occur without notice.  Providers should report  the procedure and related codes that most accurately describe the particular patient’s medical condition, procedures performed, and products used based on the provider’s experience and Medicare rules and guidelines and other payer requirements.  Zimmer Biomet specifically disclaims liability or responsibility for the results or consequences of any actions taken in reliance on information and material about reimbursement.

Ordering VISCO-3 Sodium Hyaluronate is easy and convenient. The product may be ordered through your Zimmer Biomet sales representative, by phone or fax.

Orders must be placed before 2:30pm Eastern time to ensure same day shipping

Orders will not ship on Fridays

Product #: 00-1111-001-03

Telephone: 1-800-348-2759

Fax: 574-372-4319

Zimmer Biomet Customer Service Hours: Monday – Friday, 8 am – 6 pm EST.

Additional Information

  1. Non-Inferiority Study Comparing 3 Weekly Injections of SUPARTZ® vs 3 Weekly Injections of Euflexxa® for Knee OA. https://clinicaltrials.gov/ct2/show/NCT02110238?term=Supartz&rank=2.
  2. VISCO-3 Sodium Hyaluronate Summary of Safety and Effectiveness Data (SSED)

 

*In this study (NCT02110238), VISCO-3 is called Supartz.

**SSED refer to Euflexxa as ‘commercially available hyaluronan’.

Legal Manufacturer:

Zimmer, Inc.
1800 West Center Street
Warsaw, Indiana 46580 USA

VISCO-3™ and Supartz® are trademarks of Seikagaku Corporation. Euflexxa ® is a trademark of Ferring B.V. LLC.


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This material is intended for health care professionals.  Distribution to any other recipient is prohibited.
For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the package insert and information on this website. To obtain a copy of the current Instructions for Use (IFU) for full prescribing and risk information, please call 1-800-348-2759, press 4 for 411 Technical Support.