Friday, May 28, 2004 2:09:17 PM
Anika Therapeutics Starts Clinical Trial for Facial Aesthetics; Initiation of Trial Meets Key Company Goal
May 10, 2004 07:30:00 AM ET
Anika Therapeutics, Inc. ANIK today announced the start of a pivotal U.S. clinical trial for its hyaluronic acid (HA)-based cosmetic tissue augmentation (CTA) therapy. The trial is designed to evaluate the effectiveness of CTA for correcting nasolabial folds. Future uses of this product may include applications for other facial wrinkles, scars and lip augmentation.
With its CTA therapy, Anika aims to enter the market for tissue augmentation, one of the major developing markets for HA-based therapies behind osteoarthritis and ophthalmic applications. Anika already has multiple products that address each of the other aforementioned markets. HA-based products represent the largest segment of the global tissue filler market.
The U.S. market for tissue filler applications in 2003 was approximately $60 million and represented sales primarily from collagen-based products. With the introduction of two HA-based products into the United States in 2004, the market is projected to grow to approximately $175 million within three years, according to Medtech Insight, LLC.
"The unique biophysical characteristics and inherent safety of HA make it ideal for correcting dermal defects," said Charles H. Sherwood, Ph.D., president and chief executive officer. "We believe our CTA therapy, which is based on Anika's proprietary technology for chemically modified HA, will provide unique benefits over currently marketed products."
The trial is designed to evaluate CTA for the correction of nasolabial folds in comparison to a leading commercial dermal filler made from collagen. The randomized trial will be conducted by dermatologists and plastic surgeons at up to 10 centers throughout the United States and involve approximately 200 patients, who will receive contralateral treatments with CTA and collagen. Treatments will be administered via injection to obtain optimal correction. Patients will then be monitored for six to 12 months following initial treatment.
"Anika's main focus, following the recent U.S. launch of OrthoVisc for osteoarthritis of the knee, is investing in and advancing other HA products in our pipeline," Sherwood said. He added that the company is actively pursuing discussions with potential development and marketing partners interested in collaborating on the advancement and commercialization of CTA.
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