The therapy, designed to treat osteoarthritis of the knee, is a combination of cross-linked hyaluronic acid and triamcinolone hexacetonide. The trial’s primary endpoint compared the pain reduction experienced by patients treated with Cingal compared to those treated with just TH at 26 weeks.
Anika said that although Cingal achieved greater pain reduction numerically, the difference was not statistically significant.
“While it has been observed that TH has a longer duration of effect than other corticosteroids, the results in this study were surprising. Nevertheless, the patient response to Cingal in this study was strong as patients received statistically and clinically meaningful rapid and long-lasting improvement in symptoms compared with baseline, consistent with the previous study as well as my experience in my practice,” global principal investigator Dr. Laszlo Hangody said in prepared remarks.
“While we expected Cingal to perform as well as it did, we were surprised that the difference in pain reduction seen in this trial did not reach statistically significant levels at six months,” president & CEO Joseph Darling added. “We will, however, continue to monitor the results of the ongoing 3-month extension study. We are actively reviewing the data and our plan is to work closely with regulators to come to an understanding of the next steps required to gain U.S. regulatory approval of Cingal.