22 June 2018 - - Bedford, Massachusetts-based orthopedic medicines company Anika Therapeutics, Inc. (NASDAQ: ANIK) has released results from its Cingal 16-02 clinical trial, an active-comparator Phase III study being conducted to support US registration, the company said.
The 16-02 trial compared Cingal, a viscosupplement combination of cross-linked sodium hyaluronate (HA) and triamcinolone hexacetonide (TH), with TH alone and cross-linked HA in treating patients with osteoarthritis in the knee.
The primary endpoint was a comparison of the pain reduction of Cingal compared with TH alone at 26-weeks. While Cingal achieved greater pain reduction numerically at every time point in the study, the difference at 26-weeks did not reach statistical significance.
Follow-up of patients continues in a prospectively designed extension phase to the study, which will gather data through 39-weeks.
Anika develops, manufactures, and commercializes more than 20 products, based on its proprietary hyaluronic acid technology, for patients with degenerative orthopedic diseases and traumatic conditions.
The company's orthopedic medicine portfolio, used along the continuum of care from palliative pain management to regenerative cartilage repair, includes Orthovisc, Monovisc, And Cingal, which alleviate pain and restore joint function by replenishing depleted HA, and Hyalofast, a solid HA-based scaffold to aid cartilage repair and regeneration.