Prescribing Information
Important Safety Information
For Patients

Clinical Safety 


& Efficacy

In a randomized controlled, single injection, active-comparator clinical study where HYMOVIS® ONE was compared to a leading, commercially available, single-injection HA viscosupplement product1,2:

HYMOVIS® ONE delivered comparable and substantial pain relief and similar results for safety, with no pseudoseptic reactions and no serious adverse events, at 12-weeks (3 months) and 26-weeks (6 months).1,2

Substantial knee OA pain relief over 6 months1
HYMOVIS® ONE also demonstrated statistically significant improvements in Physical Function (WOMAC Function) at 6 months, favoring HYMOVIS® ONE compared to the other commercially available HA-viscosupplement.†1,2,7

Change from baseline in WOMAC Function (WOMAC C) Scores

HYMOVIS® ONE
(N = 175)		 MONOVISC®
(N = 172)
Baseline 26.57±11.51 (N=175) 28.3±11.10 (N=172)
Changes from baseline
Week 4 -11.79±10.07 (N=173) -12.62±10.82 (N=169)
Week 12 -14.80±11.69 (N=170) -15.00±12.58 (N=168)
Week 26† -16.26±12.03 (N=172) -15.24±13.68 (N=170)
†Statistically significant improvements (changes) at 26 weeks (p = 0.0367) in WOMAC Function scores, from baseline, favoring HYMOVIS® ONE.1,2,7
In OA knee pain patients, HYMOVIS® ONE provides clinically meaningful benefits for reducing pain and improving joint function1,2
In an EU post-market clinical study (Bernetti A et al., 2021)5
A single HYMOVIS® ONE injection provides a rapid, lasting, and safe response in regular sports players (ages 18-64) affected by Symptomatic OA knee pain5

KOOS Scores Improvements:

KOOS mean scores (knee-function, knee-pain, symptom, activity of daily living, and quality of life) showed statistically significant increase (p<0.001) at all follow-up visits (Day 30, 90, 180, 360) compared to baseline values.5

An increase in KOOS scores indicate clinical study participants’ improvements

Improvements in VAS and WOMAC Scores:

Pain scores (VAS, WOMAC-A) and WOMAC-C function scores showed significant reductions at all observed timepoints (Day 30, 90, 180, 360) from baseline values.5

A decrease in VAS pain, WOMAC pain and WOMAC function scores indicate clinical study participants’ improvements

Biomechanical GAIT Improvements:

Mean GAIT cadence and mean GAIT velocity demonstrated significant improvements from baseline at Day 30, Day 90, and Day 180 (6 months).5

Cadence assessed through GAIT analysis. Mean cadence (step/min) at baseline is compared to the mean cadence recorded at each follow-up visit.

Velocity assessed through GAIT analysis. Mean velocity (m/s) at baseline is compared to mean velocity recorded at each follow-up visit.

In this study (Bernetti A et al., 2021), the product is referred to as HYMOVIS® Mo.RE. in Europe. It is the same as HYMOVIS® ONE in the U.S.5

Study design: The study investigated the efficacy and safety of a single HYMOVIS® ONE injection (32mg/4mL) for the treatment of adult regular sports players affected by knee OA arising from overuse injuries. Patients were prospectively enrolled if regularly practicing sports and diagnosed with Kellgren-Lawrence grade I-III OA. They received a single HYMOVIS® ONE intra-articular injection and were evaluated at 30, 90, 180, and 360 days.5
Significant improvements in subjective and objective measures over 6 months from baseline5
In an EU post-market clinical study (Pavelka K et al., 2020)6
A 32mg/4mL single-injection HYMOVIS® ONE demonstrated safety and efficacy in treating symptomatic knee OA pain comparable to a commercially available higher volume 6mL HA single-injection viscosupplement product6**
Excellent Safety Profile and Sustained Efficacy6

**The study assessed dosage response outcome comparisons among three different HA doses in a single-injection: HYMOVIS® ONE 32 mg/4 mL, HYMOVIS®
48 mg/6 mL, Synvisc® ONE 48 mg/6 mL.


‡The HYMOVIS® 48 mg/6 mL single-injection dosage is not FDA-approved in the US.
Two patients treated with Synvisc-One withdrew due to injection site joint inflammation. No significant differences were observed among the treatment groups for all the study performance and safety endpoints6

Study design: Sixty-two knee OA patients were prospectively recruited and randomly assigned to a single injection of Hymovis 4mL/32mg (n=20) or 6 mL/48 mg (n=22), or Synvisc-One 6 mL/48 mg (n=20), and assessed through the Western Ontario McMaster University Osteoarthritis Index (WOMAC) on a monthly basis up to 6 months.

Indication

HYMOVIS® ONE 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® ONE is contraindicated in patients with known hypersensitivity (allergy) to hyaluronate preparations or gram-positive bacterial proteins. Do not administer

HYMOVIS® ONE to patients with infections or skin diseases in the area of the injection site or joint. The safety and effectiveness of HYMOVIS® ONE have not been established in pregnant women, nursing mothers, or children, or for use in joints other than the knee, or for concomitant use with other intra-articular (IA) injections. The effectiveness of repeat treatment cycles of HYMOVIS® ONE has not been established. No serious adverse events or pseudoseptic reactions were reported in the HYMOVIS® ONE clinical study.

The adverse events experienced and reported in the HYMOVIS® ONE clinical study were joint swelling, metatarsalgia, neck pain, and headache.

 

Rx Only. See package insert for full prescribing information, including indications, contraindications, adverse events, warnings, precautions, and side effects.

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References:
1. HYMOVIS® ONE Summary of Safety and Effectiveness Data (SSED) P150010/S005
2. HYMOVIS® ONE Package Insert. Fidia Farmaceutici S.p.A. Abano Terme, Italy; 2025
5. Bernetti A, Agostini F, Alviti F, Giordan N, Martella F, Santilli V, PaoloniMand MangoneM(2021) New Viscoelastic
Hydrogel Hymovis MO.RE. Single Intra-articular Injection for the Treatment of Knee Osteoarthritis in Sportsmen:
Safety and Efficacy Study Results. Front. Pharmacol. 12:673988. doi: 10.3389/fphar.2021.673988
6. Pavelka K, Bernetti A, Giordan N, Dokoupilová E, Santilli V. Dose-response of hyaluronate-based viscoelastic
hydrogels for the treatment of knee osteoarthrosis: a prospective, randomized, comparative clinical trial. Minerva
Ortop Traumatol 2020;71:45-55. DOI: 10.23736/S0394-3410.20.03967-3)
7. HYMOVIS® ONE data on file, FIDIA FARMACEUTICI S.p.A., ITALY.