05-10-2009 - Aquamid® Safe and Effective in 300-patient U.S. Clinical Trial for the Aesthetic Treatment of Facial Wrinkles

Pivotal Study Results Presented at American Society of Dermatologic Surgery (ASDS) Annual Meeting

Results of a pivotal Phase 3 clinical trial for soft volume filler Aquamid®, developed by Contura International A/S, were presented today at the annual meeting for the American Society of Dermatologic Surgery (ASDS) in Phoenix. The 12-month study shows that Aquamid® was as effective as Restylane® at 6-month follow-up and maintained effectiveness to 12-months after follow-up, while also offering an excellent safety profile by being well tolerated through 12-months. Aquamid® is used to rejuvenate or contour the face, either by restoring lost volume or by adding extra volume where needed.

"The study was highly effective and useful in terms of showing the safety and efficacy of Aquamid,” said lead presenter and study investigator, Rhoda S. Narins, M.D, Clinical Professor of Dermatology at New York University Medical School. “The findings confirm the validity of this investigational filler and offer credence to the notion of lasting soft volume fillers."

“We are excited that our 12-month U.S. clinical data demonstrates the long-term efficacy and safety of Aquamid®,” said Michael Peytz, Chief Executive Officer, Contura International A/S. “Aquamid® is poised to enter the marketplace and meet global consumer needs for true long-lasting aesthetic treatments to restore facial volume and rejuvenate the appearance. We are looking forward to submitting this data to the FDA for review.”

This is the second time Aquamid data has been presented in the U.S. A 5-year, multicenter, prospective study of 116 European patients was presented at the 2008 American Society of Aesthetic Plastic Surgery (ASAPS) annual meeting in which safety and long-term aesthetic results of Aquamid® were shown for 5 years when used for facial soft tissue augmentation and facial contouring.

About the U.S. Study
The study was a double-blind, randomized, comparative multi-center, 2-arm parallel study involving 316 patients in 13 centers across the U.S. comparing the safety and effectiveness of Aquamid® and Restylane® for the aesthetic treatment of nasolabial folds. Subjects were randomly assigned to receive either Aquamid® or Restylane® using a 2:1 radio, and were allowed up to two touch-up treatments. The study showed that the two products were safe and well tolerated through 12-months after treatment. Aquamid® was found to be as effective as Restylane® 6 months after treatment on the improvement in the Wrinkle Assessment Scale (WAS) and maintained effectiveness till 12 months after treatment. At the 12 months follow up, more subjects rated the results with Aquamid as Improved than with Restylane. (p=0.009) A Pre-Marketing Application (PMA) for Aquamid® for mid-to-deep sub-dermal implantation for the aesthetic treatment of moderate to severe facial wrinkles and folds, such as nasolabial folds, is expected to be submitted to the U.S. Food and Drug Administration (FDA) by the end of 2009.

About Aquamid®
Aquamid® is a soft volume filler that gives a natural look and feel. Produced using Contura’s patented hydrogel technology, Aquamid® is composed of 97.5% sterile water and 2.5% cross-linked polyacrylamide. The Aquamid® hydrogel is homogeneous: it contains no microparticles; hence its filling effect is due solely to the injected volume. Unlike particle-based fillers, the hydrogel does not rely on an intended foreign body reaction to achieve the desired augmentation. Therefore, the filling effect is immediate and predictable. Moreover, the hydrogel does not cause tissue hardening or fibrosis. No skin test is needed before treatment. The hydrogel integrates completely into the tissue and does not migrate from the injection site. It stays soft, feels like a natural part of the tissue and follows tissue movements. Because the hydrogel does not degrade over time, it provides augmentation that lasts for years. Aquamid® was approved in Europe in 2001 for facial augmentation and minor body contouring and is available in several countries in Europe, Asia, the Middle East and South America. Aquamid® is used mainly for treating nasolabial folds, lip augmentation, cheek contouring, nose enhancement and for treating facial lipoatrophy. Over 350,000 Aquamid® injections have been performed to date. Aquamid® is currently under clinical investigation in the U.S. for the aesthetic treatment of nasolabial folds and is not approved for sale in the United States.