The US Food and Drug Administration (FDA) has approved Anika Therapeutics’ MONOVISC for treatment of pain due to osteoarthritis (OA) of the knee.
Approval is based on safety and effectiveness data from a randomised, controlled, double-blind multi-centre US clinical trial encompassing a total of 369 patients suffering from OA of the knee at 31 centres in the US and Canada.
The objective of the study was to evaluate the safety and effectiveness of MONOVISC for the treatment of joint pain.
In the trial, patients were randomised to either MONOVISC or control (saline injection) and were evaluated for improvement in pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at follow-up assessments out to 26 weeks.
According to the safety analysis, MONOVISC had an low-rate of adverse events.
MONOVISC is a single injection supplement to synovial fluid of the osteoarthritic joint, indicated to treat pain and improve joint mobility in these patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics.
The drug includes a sterile, clear, biocompatible, resorbable, viscoelastic solution composed of partially cross-linked sodium hyaluronate (NaHA) in phosphate buffered saline.
It also includes high molecular weight, ultra-pure natural hyaluronan, derived from bacterial cells and is cross-linked with a proprietary cross-linker.
The product was designed to deliver a comparable HA dose to the company’s three-injection viscosupplement, ORTHOVISC, in the convenience of a single 4ml intra-articular injection.
DePuy Synthes, Mitek Sports Medicine (Mitek), an orthopedic sports medicine company, is responsible for marketing MONOVISC in the US.
As part of the licensing deal with Mitek, Anika will receive a milestone payment of $5m upon first commercial sale of the product in the market.
The deal also calls for potential additional payments contingent on achieving certain performance and sales threshold milestones, on top of product transfer and royalty fees.
Anika Therapeutics president and CEO Charles Sherwood said: "With FDA approval of MONOVISC, we can be better positioned with our single and multi-injection products to meet the varying needs of physicians and patients.
"We are moving forward rapidly with Mitek Sports Medicine to capitalise on the strengths of our viscosupplementation portfolio.
"Commercial introduction for MONOVISC in the US is planned to take place in conjunction with the annual meeting of the American Academy of Orthopedic Surgeons to be held in New Orleans, 11-15 March."
MONOVISC is currently sold in several territories, including Canada, the UK and many countries in the Middle East, Europe and Asia.
Image: MRI of osteoarthritis in the knee, with characteristic narrowing of the joint space. Photo: courtesy of Scuba-limp.