Bioventus said today that its Durolane single-injection, hyaluronic acid product won FDA approval for the treatment of pain associated with knee osteoarthritis.
When a person develops osteoarthritis in their knee, the cartilage breaks down and so does the synovial fluid that provides lubrication to joint tissues. Hyaluronic acid provides cushioning and lubrication to the knee, according to Bioventus.
The Durham, N.C.-based company said it plans to launch Durolane in the U.S. in early 2018.
“More than 20 million Americans are afflicted with knee osteoarthritis and there is no cure, but the associated pain can be managed,” CEO Tony Bihl said in prepared remarks. “Durolane has been a proven knee OA pain reliever for more than 15 years, improving the lives of more than one million people worldwide. It will join our current offerings to provide even more efficacious treatment options for U.S. patients, physicians and payers.”
The company’s osteoarthritis porfolio includes a three-injection Gelsyn-3 hyaluronic acid product and a five-injection Supartz Fx product. Bioventus’ Durolane is available in 25 countries, including Canada, Mexico and Australia.