A double-blind, multi-center, randomized, controlled trial was
conducted in which VISCO-3 Sodium Hyaluronate*was compared to
Euflexxa® 1% Sodium Hyaluronate (NCT 02110238). The study
enrolled a total of 421 subjects.1
Safety 2
Safety analysis included all subjects who received at least one
injection (n = 211 Euflexxa, n = 209 VISCO-3). There was no
significant difference in the total Treatment-Emergent Adverse Events
(TEAEs) with VISCO-3 Sodium Hyaluronate compared to Euflexxa (Table
1). A total of seven serious adverse events (SAE) were reported,
however none were considered to be related to the study devices. There
were no reports of pseudoseptic events or allergic reactions in the
study. The most common device related adverse events in the VISCO-3
group were arthralgia (1%), joint swelling (1.4%) and injection site
pain (1%).
Table 1: Overall Summary of Treatment-Emergent Adverse Events (TEAEs)
Category |
Euflexxa (N=211) n(%) |
VISCO-3 (N=209) n(%) |
Subjects with ≥ 1 TEAE |
109 (51.7) | 107 (51.2) |
Subjects with ≥ 1 TEAE related to
study device | 14
(6.6) | 9 (4.3)
|
Subjects with ≥ 1 serious adverse
event (SAE) | 6
(2.8) | 1 (0.5)
|
Effectiveness2
The analysis of effectiveness was based on the 384 evaluable
patients over the 12 week time point. The effectiveness of the
treatments was measured as WOMAC VAS pain subscale change from base
line (CFB). The Key effectiveness outcomes are presented below (Table
2). The mean baseline WOMAC VAS pain subscale was 57.83 in the VISCO-3
Sodium Hyaluronate group and 58.40 in the Euflexxa Sodium Hyaluronate
group. The least squares mean for CFB for VISCO-3 Sodium Hyaluronate
minus that of the control gives a WOMAC VAS subcale sore of -3.30 mm.
Table 2: Effectiveness Analysis; CFB of WOMAC VAS Pain Subscale
Through Study Duration
Average over Weeks 3, 6, and 12 |
Euflexxa (N=189) |
VISCO-3 (N=195) |
CFB Difference |
Baseline WOMAC VAS Pain (mm)
(Mean[SD]) | 58.40
(8.977) | 57.83
(9.654) | |
LS Mean (standard error [SE]) of
change from Baseline (CFB) | 30.15 (1.303) | 26.85 (1.270) | -3.30 (1.762) |
95% CI | 27.59-32.71 | 24.35-29.35 | -6.77-0.17 |
VISCO-3 Sodium Hyaluronate demonstrated noninferior pain relief
compared to patients treated with Euflexxa Sodium Hylauronate. This is
concluded based upon the fact that the lower bound of the 95% CI
(-6.77 mm) is greater than -8 mm. On average, patients treated with
VISCO-3 Sodium Hyaluronate saw a 52% reduction in pain at week 12
compared to baseline.
Post Market Experience2
Literature has shown that repeated treatment cycles of the VISCO-3
Sodium Hyaluronate formulation contain no evidence of an increased
safety risk. The frequency and severity of adverse events occurring
during repeat treatment cycles did not increase over that reported for
a single treatment cycle.