# Single-injection hyaluronic acid treatment demonstrates non-inferiority in the relief of symptomatic knee osteoarthritis: A randomized double-blind, multi-center controlled study

## TL;DR

A single injection of HYMOVIS® ONE provides similar pain relief as MONOVISC® for knee osteoarthritis, with benefits lasting up to 26 weeks.

## Contribution

Demonstrates non-inferiority of a single HYMOVIS® ONE injection compared to MONOVISC® in treating knee osteoarthritis.

## Key findings

- HYMOVIS® ONE showed 65% pain reduction at week 12 and 73% at week 26, comparable to MONOVISC®.
- Non-inferiority was confirmed with a p-value of 0.0003, and HYMOVIS® ONE showed better function scores at week 26.
- Both treatments were well tolerated, with sustained improvements in pain and function over 26 weeks.

## Abstract

To compare two sodium hyaluronate formulations (HYMOVIS® ONE and MONOVISC®) for single intra-articular (IA) injection in patients with knee osteoarthritis pain.

This randomized, controlled study included 347 subjects allocated to two treatment arms: HYMOVIS® ONE (n = 175) and MONOVISC® (n = 172). The primary endpoint assessed non-inferiority of HYMOVIS® ONE versus MONOVISC® based on change from baseline in the WOMAC LK3.1 A1 Pain subscale. Secondary outcomes evaluated patient response using OMERACT-OARSI criteria, changes in WOMAC stiffness and function scores, health-related quality of life (SF-12), global assessments by patients and clinicians, and rescue medication use.

The mean WOMAC LK3.1 A1 walking pain subscale score decreased significantly from baseline at week 12 in both groups, with reductions of 65 % for HYMOVIS® ONE and 66 % for MONOVISC®. At week 26, reductions were 73 % for HYMOVIS® ONE and 69 % for MONOVISC®. The non-inferiority test yielded a p-value of 0.0003. Clinically significant change from baseline was observed for all secondary endpoints. For the WOMAC LK3.1 Function subscale, the comparison between groups at week 26 showed a statistically significant difference (p = 0.0367) favoring HYMOVIS® ONE. Both treatments were well tolerated.

A single injection of HYMOVIS® ONE was well tolerated and non-inferior to MONOVISC®, with improvements across all study endpoints maintained through 26 weeks, indicating sustained symptomatic relief of knee OA.

NCT06528600 (www.clinicaltrials.gov).