Genzyme reported negative results from a pivotal trial of hylastan for the treatment of pain associated with osteoarthritis of the knee. This double-blind, active-control study enrolled 400 subjects in North America and Europe. Subjects were randomized to receive two intra-articular injections of hylastan delivered two weeks apart, a single injection of hylastan, or an injection of a corticosteroid. They were then evaluated for 26 weeks. Each of the three treatment arms showed a statistically significant reduction in knee pain from baseline.
However, significance was not reached between the hylastan arm and the corticosteroid arm. Thus, the primary endpoint of demonstrating that hylastan provides superior pain relief than steroids was not achieved. Based on the results, Genzyme plans to fully analyze the data in order to determine a future course of action.
The company has another avenue toward reaching its goal of a single injection viscosupplementation -- product. Genzyme is currently seeking to market Synvisc-One, a combined-dose regimen of hylan G-F 20 provided in a single injection, in the United States and Europe.
“It is now clear that we will focus our efforts on bringing Synvisc-One to the market. We are confident that simplifying the treatment process will encourage a greater number of physicians and patients to seek the benefits of viscosupplementation to help manage OA knee pain. We will continue to analyze the findings from the hylastan study to determine how this product fits into our longer-range strategy, as we continue to invest in bringing innovation to this field,” said Ann Merrifield, president of Genzyme Biosurgery.