OrthogenRx, Inc., a medical device company focused on the development and commercialization of treatments for musculoskeletal conditions including osteoarthritis (OA) has announced the launch of TriVisc® (sodium hyaluronate) for the treatment of patients with osteoarthritic (OA) knee pain who have failed to get adequate relief from simple painkillers or from exercise and physical therapy. TriVisc is a solution of highly purified hyaluronic acid (sodium hyaluronate; HA) and helps supplement the viscous properties of the fluid in the knee joint. TriVisc is administered by a healthcare professional in 3 injections in the knee given at weekly intervals. In clinical studies TriVisc has been shown to provide patients with months of pain relief and can be repeated if the pain returns.
TriVisc is the first medical device in over 20 years to demonstrate clinical effectiveness and secure FDA approval under Section 216 of the Food and Drug Administration Modernization Act (1997). TriVisc is derived from a biofermentation process, which means that patients with allergies to chickens, eggs, feathers and other avian products are not at risk for an avian reaction that might arise from some other products derived from chicken combs. The TriVisc formulation is approved in 63 countries outside the US, with over 35 million doses administered worldwide. From a cost perspective, TriVisc is the lowest priced (based on Wholesale Acquisition Cost or ‘retail’ price), three injection, HA product derived from a biofermentation process on the US market.
“This approval allows OrthogenRx to stay the course in continuing to provide fair and consistent pricing of our products to healthcare professionals and patients. It is our continuing mission to provide safe and efficacious treatment options to our patients for the treatment of osteoarthritis knee pain,” said Michael Daley, PhD, Co-President, Co-Chief Executive Officer, and Founder of OrthogenRx, Inc.
TriVisc is the second product to receive FDA approval in the OrthogenRx portfolio in just 2 years. GenVisc 850, which is a 5-injection regimen of sodium hyaluronate, was previously approved by the Agency in September 2015.
TriVisc and GenVisc 850 were developed in collaboration with Meiji Seika Pharma Co., Ltd. (Japan) and subsidiary, Tedec-Meiji Farma S.A (Spain). TriVisc formulation has been approved in over 63 countries (outside US) under the Adant® and related brands and distributed by Meiji Seika Pharma Group and partners.