The data showed that treatment with Cingal yielded better immediate and short-term pain relief compared to hyaluronic acid alone and better pain and stiffness relief through 26 weeks compared to saline. The data was published in the journal Cartilage.
“We are excited to share published, peer-reviewed Phase III data that validates the efficacy, safety and clinical significance of our novel viscosupplement, Cingal,” president & CEO Charles Sherwood said in prepared remarks. “Cingal fulfills a tremendous unmet clinical need for a low-volume corticosteroid and hyaluronic acid combination viscosupplement that has an established track record of safety and efficacy, and provides immediate and long-term relief from knee OA symptoms for 6 months and potentially beyond.”
The 368-patient trial randomized participants to receive a single injection of Cingal, Monovisc (hyaluronic acid) or saline.
At 12 weeks and 26 weeks, Cingal reduced pain by 70% and 72%, respectively, compared to saline. The combination therapy also demonstrated rapid pain relief, improving pain by 59% after 1 week and 68% at 3 weeks.
After 1 and 3 weeks, Cingal was significantly better than Monovisc for most endpoints, Anika reported. Cingal and Monovisc performed similarly from 6 weeks to 26 weeks.
The company also reported that there were no serious adverse events related to Cingal.
“Steroid injections and hyaluronic acid-based viscosupplements are two forms of effective non-surgical interventions to manage knee osteoarthritis,” lead author Dr. Laszlo Hangody said. “By combining a proven viscosupplement, Monovisc, with an established steroid in a single injection, Cingal gives patients a safe, convenient and highly effective treatment option for immediate and sustained relief from the debilitating symptoms of knee OA.”