Bioventus announced the availability of Gelsyn-3 (hyaluronic acid 0.8%), an injectable indicated for pain associated with osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy and simple analgesics (eg, acetaminophen).
Gelsyn-3 is a 3-injection regimen that provides pain relief for up to 6 months. The efficacy of Gelsyn-3 was compared with Synvisc (hylan G-F 20 0.8%) in a study involving 380 patients who were observed for a period of 26 weeks. The primary outcome measure was WOMAC pain score at 26 weeks.
The study found that patients administered the Gelsyn-3 regimen had a 30.8mm WOMAC pain subscore mean reduction from baseline vs. 29.4mm for patients administered the Synvisc regimen. In addition, 93–97% of patients and investigators scored global tolerability as “good” or “very good.” The Synvisc regimen group experienced five treatment-related adverse events vs. one event reported in the Gelsyn-3 regimen group. There was also a lesser need (8.7%) for rescue medication with Gelsyn-3 in the intent-to-treat population compared with Synvisc (P=0.065). The overall efficacy and safety of Gelsyn-3 regimen was comparable to Synvisc.
Each injection provides a highly purified solution of hyaluronic acid. It is a biofermentation-based formulation that may eliminate the risk of avian allergies and sensitivities. Gelsyn-3 is supplied as a single prefilled syringe containing solution for intra-articular injection.
For more information call (800) 836-4080 or visit Gelsyn3.com.