Clinical Studies – Hymovis for Healthcare Professionals

HYMOVIS^® has been demonstrated to reduce OA knee pain^4-7

Comparison of patients’ OA knee pain from baseline at 6 months

In pivotal trial:

34% reduction in WOMAC/VAS pain score⁴

In post-market clinical trial:

37% reduction in VAS for pain scores⁵

In real-world clinical practice retrospective study:

57% reduction in VAS for pain (resting) scores⁶
47% reduction in VAS for pain (movement) scores⁶
56% reduction in total WOMAC score⁶

Post-market clinical data

Significantly improved total WOMAC and VAS for pain scores compared with corticosteroid treatment⁵

Total WOMAC scores⁵

VAS for pain scores⁵

HYMOVIS^® delivered a 37% reduction at week 26 from baseline.

Study Summary: Bisicchia, 2016

Demonstrated reductions in WOMAC pain and stiffness scores and improvements in WOMAC physical function that were maintained for 52 weeks with a 2-cycle regimen⁷

WOMAC pain, stiffness, and physical function scores (mean +/-SE)⁷

Study Summary: Benazzo, 2016

Statistically significant improvements in VAS pain (at rest and on movement) and mean WOMAC scores⁶

Trend in pain scores and WOMAC scores after two HYMOVIS^® injections

Study Summary: Priano, 2017

Indication

HYMOVIS^® 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 or simple analgesics (e.g., acetaminophen).

Important Safety Information

HYMOVIS^® is contraindicated in patients with known hypersensitivity (allergy) to hyaluronate preparations or gram-positive bacterial proteins. Do not administer HYMOVIS^® to patients with infections or skin diseases in the area of the injection site or joint. The safety and effectiveness of the use of HYMOVIS^® have not been tested in pregnant women, nursing mothers, or children. The safety and effectiveness of the use of HYMOVIS^® in joints other than the knee, or for use concomitantly with other intra-articular (IA) injections, have not been established. The effectiveness of repeat treatment cycles of HYMOVIS^® has not been established.

Arthralgia, transient pain, or swelling may occur after the IA injection. The incidence of arthralgia in the clinical study for HYMOVIS^® was equivalent to the control group. No serious adverse events or pseudoseptic reactions were reported. Transient increases in inflammation following any IA hyaluronan injection have been reported in some patients with inflammatory joint conditions.

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^aData obtained from the ANTIAGE National Registry (Italy): Associazione Nazionale por la Terapia Intra Articcolare con Guida Ecografica (ANTIAGE) - A nonprofit database of clinical data on effects of ultrasound-guided intra-articular viscosupplementation

The only 2-injection hyaluronic acid regimen for osteoarthritis knee pain

HYMOVIS® has been demonstrated to reduce OA knee pain4-7

Comparison of patients’ OA knee pain from baseline at 6 months

Post-market clinical data

Significantly improved total WOMAC and VAS for pain scores compared with corticosteroid treatment5

Total WOMAC scores5

VAS for pain scores5

HYMOVIS® delivered a 37% reduction at week 26 from baseline.

Demonstrated reductions in WOMAC pain and stiffness scores and improvements in WOMAC physical function that were maintained for 52 weeks with a 2-cycle regimen7

WOMAC pain, stiffness, and physical function scores (mean +/-SE)7

Statistically significant improvements in VAS pain (at rest and on movement) and mean WOMAC scores6

Trend in pain scores and WOMAC scores after two HYMOVIS® injections

References

STUDY SUMMARY: BISICCHIA S, 2016

HYMOVIS® (HYADD® 4) Versus Methylprednisolone Acetate in Symptomatic Knee Osteoarthritis: A Single-centre Single Blind Prospective Randomised Controlled Clinical Study With a 1-year Follow-up5

Study design

Objective

Study population

Intervention

Primary endpoint

STUDY SUMMARY: BENAZZO F, 2016

A Multi-centre, Open-label, Long-term Follow-up Study to Evaluate The Benefits of a New Viscoelastic Hydrogel (HYMOVIS®) in The Treatment of Knee Osteoarthritis7

Study design

Objective

Study population

Intervention

Primary endpoint

Secondary endpoints

STUDY SUMMARY: PRIANO F, 2017

Post-market retrospective study evaluating real-world use of HYMOVIS®

Early Efficacy of Intra-articular HYADD® 4 (HYMOVIS®) Injections for Symptomatic Knee Osteoarthritis6

Study objective

Study design

The only 2-injection
hyaluronic acid regimen for
osteoarthritis knee pain

HYMOVIS^® has been demonstrated to reduce OA knee pain^4-7

Significantly improved total WOMAC and VAS for pain scores compared with corticosteroid treatment⁵

Total WOMAC scores⁵

VAS for pain scores⁵

HYMOVIS^® delivered a 37% reduction at week 26 from baseline.

Demonstrated reductions in WOMAC pain and stiffness scores and improvements in WOMAC physical function that were maintained for 52 weeks with a 2-cycle regimen⁷

WOMAC pain, stiffness, and physical function scores (mean +/-SE)⁷

Statistically significant improvements in VAS pain (at rest and on movement) and mean WOMAC scores⁶

Trend in pain scores and WOMAC scores after two HYMOVIS^® injections

HYMOVIS^® (HYADD^® 4) Versus Methylprednisolone Acetate in Symptomatic Knee Osteoarthritis: A Single-centre Single Blind Prospective Randomised Controlled Clinical Study With a 1-year Follow-up⁵

A Multi-centre, Open-label, Long-term Follow-up Study to Evaluate The Benefits of a New Viscoelastic Hydrogel (HYMOVIS^®) in The Treatment of Knee Osteoarthritis⁷

Post-market retrospective study evaluating real-world use of HYMOVIS^®

Early Efficacy of Intra-articular HYADD^® 4 (HYMOVIS^®) Injections for Symptomatic Knee Osteoarthritis⁶