Study Summaries

HYADD4® versus methylprednisolone acetate in symptomatic knee osteoarthritis: a single-centre single blind prospective randomised controlled clinical study with a 1-year follow-up

S. Bisicchia, G. Bernardi, C. Tudisco

Hymovis (HYADD4®, Fidia Farmaceutici Spa, Abano Terme, Italy) is a new hydrogel HA-based product, which provides elevated cushioning features or a long intra-articular residence time compared to previous molecules.

This is a single-center, single-blind, prospective randomized controlled clinical study to compare the clinical results and the quality of life in patients with symptomatic knee osteoarthritis randomized to either a new HA (Hymovis®) or corticosteroid (CS). A separate rationale was to evaluate the safety profile of Hymovis®.

All the patients were prospectively randomly assigned to receive 2 injections of either Hymovis® or CS, and were evaluated before the injections and at 6, 12, 26 and 52 weeks.

Primary end point: WOMAC total score at 26 weeks;
Secondary end points: WOMAC total score, VAS for pain, and SF-36 score at any time point.

Results

  • Patients in the Hymovis® group obtained significantly better WOMAC total scores than CS group at 6 (p<0.0001), 12 (p=0.01) and 26 weeks (p<0.0001) (fig 1).
  • Considering VAS for pain, patients in the Hymovis® group obtained significantly better results than CS group at 12 weeks (p=0.0001) and 26 weeks (p=0.0004), indicating that Hymovis® has a greater therapeutic effect (fig 2).
  • Considering SF-36 scores, patients significantly improved compared to baseline data and scores remained quite stable in the Hymovis® group up to 26 weeks.

Hymovis® clinical performance

While patients in both groups obtained good results in the short term (6 weeks), patients in the Hymovis® group obtained better results at 26 weeks in terms of knee function, WOMAC total score (p<0.0001), pain VAS (p=0.004) and quality of life.


WOMAC total scores at the different time points in Hymovis® and corticosteroids (CS) group


VAS for pain scores at the different time points in Hymovis® and corticosteroids (CS) group



HYMOVIS® Demonstrates Superior Biomechanical Lubricating Properties

New data presented March 22, 2017 at the Orthopedic Research Society Annual Meeting highlights the superior lubricating properties of HYMOVIS® against all other competitor HA products evaluated.

HYMOVIS® has exceptional lubricating properties in moving cartilage to a low-friction regime. The study provides a unifying framework to evaluate the potential clinical efficacy of injectable hyaluronic acid therapies.

Fidia Farmaceutici S.p.A., a world leader in the research, development and manufacturing of hyaluronic acid (HA) - based products and its wholly owned subsidiary, Fidia Pharma USA Inc., announces new data were presented at the Annual Meeting of the Orthopaedic Research Society (ORS) in San Diego, CA, March 19-22, 2017.

Scientists from Fidia Farmaceutici S.p.A. and the research group led by Dr. Lawrence Bonassar, Professor at the Meinig School of Biomedical Engineering at Cornell University evaluated the in vitro rheological and tribological properties of six commercial HA products used for the treatment of pain in osteoarthritis (OA) of the knee. “In our research, we demonstrated that there are clear differences in the lubricating abilities of this cohort of HA products. HYMOVIS® is an exceptional viscous lubricant in moving cartilage to a low-friction regime, having superior biomechanical lubricating properties amongst all the HAs evaluated.” In addition, the study approach offers a novel method to evaluate the potential clinical efficacy of injectable hyaluronic acid therapies that may be more sensitive than rheological measurements alone*.

This new data were presented in the late breaking session of the Annual Meeting of the Orthopaedic Research Society (ORS) on Wednesday, March 22, 2017 (http://www.ors.org/Transactions/63/2374.pdf). (Pending publication).

HYMOVIS® is a highly viscoelastic, non-crosslinked hydrogel bioengineered using a proprietary process that increases lubrication and shock absorption properties. This results in a natural hyaluronan similar to the hyaluronan found in the synovial fluid present in human joints. The formulation allows this unique molecule to recover its original structure, even after repetitive mechanical stress. Due to reversible hydrophobic interactions, the non-crosslinked HYMOVIS® has increased elasticity, viscosity and residence time in the joint.* Its unique molecular structure results in enhanced biomechanical properties and long-lasting efficacy, all in a convenient two-dose regimen.



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 osteoarthritis

F. Benazzo, L. Perticarini, A. Padolino, A. Castelli, P. Gifuni, M. Lovato, C. Manzini, N. Giordan

Viscosupplementation with intra-articular injection of hyaluronic acid (HA) is widely used 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.

HYMOVIS® is a newly marketed HA manufactured by Fidia Farmaceutici S.p.A., Abano Italy, and distributed by its wholly owned subsidiary, Fidia Pharma USA Inc., Parsippany, NJ. HYMOVIS® consists of an 8mg/mL hydrogel formulation of HYADD®4, a unique molecule, which is not chemically crosslinked and has a low degree of modification that increases viscosity, elasticity and joint residence time* (HYMOVIS package insert).

This is a prospective, multicentre, open label, 12 months follow-up, clinical study to evaluate the long-term benefits of 2 cycles of treatment with 2x3 ml intra-articular injections of 8 mg/ml of HYMOVIS® in the treatment of knee OA (n=49 outpatients). Each injection cycle was given at weekly intervals for two weeks, repeated at 6 months.

  • Primary objective: pain measured by WOMAC pain (A) subscore over 12 months.
  • Secondary objectives: pain stiffness and physical function; radiological progression of knee OA; patient’s response to therapy (OMERACT-OARSI); Quality of Life.

Results

  • WOMAC pain (A) subscore: a statistically significant improvement from baseline was evidenced at each time point.
  • WOMAC A1 score (pain on walking): significant improvement vs baseline (p<0.001) at 12-month follow-up.
  • WOMAC pain stiffness, physical function and total score: significant improvement by 3 months and 6 months after one intra-articular injection cycle, and up to 12 months after repeat treatment with HYMOVIS (p<0.001).
  • OMERACT-OARSI criteria: 86% responder rate reported in this study after 6 months, and 88% responder rate reported in the study at 12 months after one repeat cycle of treatment.
  • JSW reduction of 0.2mm: Study criteria defined disease progression as ≥ 0.5mm; the mean baseline in the target knee was 4.6mm and progressed to a mean value of 4.2mm at the end of the study.
  • EQ5D (Quality of Life index): significant increase vs baseline at each time point (p<0.001).

Clinical performance and safety of HYMOVIS® in the treatment of pain due to knee OA, demonstrated in previous studies has been confirmed by the results of this study.


Hear More from HYMOVIS® Patients

A breakthrough in the treatment of osteoarthritis (OA) of the knee, HYMOVIS® is helping active patients everywhere write their own story about moving past pain and back to the things they love in life.

Take a moment to learn about how a simple, two-injection regimen can be a convenient, efficient treatment of OA for your patients.

Fidia offers COMPREHENSIVE SUPPORT for your patients and your practice

The HYMOVIS Support Hotline*: 1-866-HYMOVIS (1-866-496-6847)

or www.HYMOVISonline.com

Available 9 AM to 8 PM ET, Monday through Friday
Dedicated reimbursement support
Three ways to enroll: phone, fax, or web
Patient-specific insurance verifications for medical and specialty pharmacy benefits
Comprehensive prior authorization support
Claims and appeal assistance
Billing and coding guidelines
Specialty pharmacy triage upon request
Simplified ordering, billing, and return processing
Report adverse events or a product quality complaint
Contact sales representative to order posters or brochures
Medical information
* The Hotline does not file claims for callers, nor can it guarantee that you will be successful in obtaining reimbursement. Third-party payment for medical products and services is affected by numerous factors, not all of which can be anticipated or solved by the Hotline.
No minimum order quantity
Low thresholds for contract pricing
Easy online ordering

Henry Schein

Besse

Each carton contains two blister packs, each with a single-use syringe
3.0 mL of HYMOVIS® in a 5.0-mL single-use syringe
A hyaluronan concentration of 8 mg/mL, dissolved in physiologic saline
J-Code: J7322
CPT 20610; 20611 physician administration
Available 9 AM to 8 PM ET, Monday through Friday
Hotline: 1-866-HYMOVIS (1-866-496-6847)
Dedicated reimbursement support including:
Comprehensive prior authorization support
Patient-specific insurance verifications
Billing and coding information
Claims and appeals assistance
Simple ordering process
Report adverse event or product complaints
For Customer Service, please email us at customerservice@fidiapharma.us
For product-related specific information, please contact the Medical Office at medicaloffice@fidiapharma.us
For additional information please email us at hymovis@fidiapharma.us

Fidia offers COMPREHENSIVE SUPPORT

for your patients and your practice

The HYMOVIS Support Hotline*: 1-866-HYMOVIS (1-866-496-6847)

or www.HYMOVISonline.com

Available 9 AM to 8 PM ET, Monday through Friday
Dedicated reimbursement support
Three ways to enroll: phone, fax, or web
Patient-specific insurance verifications for medical and specialty pharmacy benefits
Comprehensive prior authorization support
Claims and appeal assistance
Billing and coding guidelines
Specialty pharmacy triage upon request
Simplified ordering, billing, and return processing
Report adverse events or a product quality complaint
Contact sales representative to order posters or brochures
Medical information
* The Hotline does not file claims for callers, nor can it guarantee that you will be successful in obtaining reimbursement. Third-party payment for medical products and services is affected by numerous factors, not all of which can be anticipated or solved by the Hotline.

Hotline: 1-866-HYMOVIS (1-866-496-6847)

FIDIA offers

Comprehensive HYMOVIS® support

for your patients and your practice

Hotline: 1-866-HYMOVIS (1-866-496-6847)

Intended for US Residents Only

*Mechanical testing may not be indicative of human clinical outcomes
** From a multi-center open label study in 49 patients treated with HYMOVIS®

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