ExtremitiesRegulatory

Anika Therapeutics Files Investigational Device Exemption to Initiate Phase III Study to Expand Indication of MONOVISC® to Treat Pain Caused by Osteoarthritis of the Hip

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc., (NASDAQ: ANIK), a leader in products for tissue protection, healing, and repair based on hyaluronic acid (HA) technology today announced that it has submitted an Investigational Device Exemption (IDE) with the U.S. Food & Drug Administration (FDA) to conduct a Phase III clinical trial to support the expanded use of MONOVISC for the treatment of pain caused by osteoarthritis (OA) of the hip. MONOVISC, a single injection viscosupplement comprised of non-animal sourced hyaluronic acid, is currently approved by the FDA for the treatment of pain caused by osteoarthritis of the knee. The study will be sponsored by DePuy Synthes Mitek Sports Medicine*, a leading orthopedic sports medicine company, and Anika’s commercial partner and exclusive distributor of MONOVISC in the U.S.

Osteoarthritis is a chronic condition characterized by the degeneration of cartilage and underlying bone within a joint, which eventually leads to pain and joint stiffness. OA affects approximately 27 million Americans, and one in four adults will develop symptoms of hip OA by age 85. There is currently no cure for OA.

The IDE seeks approval for a prospective, double-blind, randomized, placebo-controlled, superiority study designed to demonstrate the efficacy of MONOVISC by measuring change in WOMAC1 A1 pain scores over a 26-week period following initial treatment. The study plans to enroll approximately 560 subjects across 20 investigational sites in the U.S., beginning in 2015.

“The submission of this IDE represents an important step towards extending the benefits of MONOVISC to patients living with the chronic pain associated with hip osteoarthritis, for whom non-surgical treatment options are currently limited,” said Dr. Charles H. Sherwood, President and Chief Executive Officer, Anika Therapeutics. “We believe the expanded indication will further enhance the clinical and commercial value of MONOVISC, and strengthen our position in the viscosupplementation market as a leading provider of innovative and effective therapies.”

About Anika Therapeutics, Inc.
Headquartered in Bedford, Mass., Anika Therapeutics, Inc. develops, manufactures, and commercializes therapeutic products for tissue protection, healing, and repair. These products are based on hyaluronic acid (HA), a naturally occurring, biocompatible polymer found throughout the body. Anika’s products range from orthopedic/joint health solutions led by Orthovisc and Monovisc, treatments for osteoarthritis, to surgical aids in the anti-adhesion and ophthalmic fields. The Company also offers aesthetic dermal fillers for the correction of facial wrinkles. Anika’s Italian subsidiary, Anika Therapeutics S.r.l., provides complementary HA products in the orthopedic/joint health and anti-adhesion fields, as well as therapeutics in areas such as advanced wound treatment and ear, nose, and throat care. Its regenerative technology advances Anika’s vision to offer therapeutic products and medical solutions that go beyond pain relief to protect and restore damaged tissue.

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