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Prescribing Information
Important Safety Information
For Patients

In a randomized controlled, single injection, active-comparator clinical study where

HYMOVIS® ONE was compared to a leading, commercially available, single-injection HA viscosupplement product:1,2

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
Line chart: Summary of results of WOMAC LK3.1 A1 comparing Hymovis One and Monovisc walking pain scores from baseline to Week 26, showing comparable pain reduction from about 2.1 to 1.2 by Week 4, sustained through Week 26
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

Line chart: KOOS Knee Function primary endpoint score rising from about 42 at baseline to about 78 by Day 360, measured at Day 30, 90, 180, and 360

An increase in KOOS scores indicates 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
Line chart: KOOS secondary endpoint scores for knee pain, symptoms, activity of daily living, and quality of life, all increasing from baseline through Day 360
A decrease in VAS pain, WOMAC pain and WOMAC function scores indicates 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
Line chart: mean gait cadence in steps per minute increasing from baseline through Day 180, with statistically significant improvement at each follow-up visit
Line chart: mean gait velocity in meters per second increasing from baseline through Day 180, with statistically significant improvement at each follow-up visit

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.
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**
Line chart from EU post-market study (Pavelka et al., 2020): Walking Pain WOMAC A1 scores for Hymovis One 32mg, Hymovis 48mg, and Synvisc One 48mg over 180 days, showing comparable pain reduction across all three treatments

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 has not been established in pregnant women, nursing mothers, or children or for use in joints other than the knee, or 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, Paoloni M and Mangone M (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.

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