Anika Therapeutics announced that it has received FDA marketing approval for Monovisc (sodium hyaluronate [NaHA] in phosphate buffered saline), a single injection viscosupplement used to treat pain and improve joint mobility in osteoarthritis (OA) of the knee in patients who have insufficient response to conservative non-pharmacologic therapies and simple analgesics.
It is the first FDA-approved single injection product with non-animal HA. Monovisc consists of high-molecular weight, ultra-pure natural hyaluronan, which is derived from bacterial cells and cross-linked with a proprietary cross-linker.
The FDA approval was based on a randomized, controlled, double-blind multi-center study of 369 patients at 31 centers in the U.S. and Canada, where Monovisc patients achieved a greater improvement from baseline in WOMAC pain score through 12 weeks vs. the control group.
Monovisc will be available as a single 4mL intra-articular injection in March 2014.
For more information, call (781) 457-9000 or visit Monovisc.com.