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Aquamid, New Wrinkle Filler, Applies for FDA Approval

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Danish company Contura has submitted a Premarket Approval Application (PMA) for a new injectable dermal filler, Aquamid, to the U.S. Food and Drug Administration (FDA) requesting marketing approval in the U.S. for the aesthetic treatment of moderate to severe facial wrinkles and folds.

The application includes a successful U.S. pivotal study, in which the safety and efficacy of Aquamid was compared to Medicis' Restylane for 12 months after treatment. The study results were presented last year at the American Society of Dermatologic Surgery's Annual Meeting and at Plastic Surgery 2009, and showed that Aquamid was as effective as Restylane at 6 months follow-up based on the study endpoints and maintained this effectiveness at 12 months follow-up. Both treatments were safe and well tolerated. Also included in the application is a study extension that followed the Aquamid-treated subjects up to two years and demonstrated a consistent effectiveness and safety profile.

If approved for the U.S. market, Aquamid will be produced at Contura's new manufacturing facility in Denmark, which was designed to meet FDA requirements, and was recently approved by the European authorities.

Aquamid is composed of 97.5% water for injection and 2.5% cross-linked polyacrylamide. The patented hydrogel is homogeneous: it contains no micro particles; 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. Aquamid does not degrade over time and provides a choice for patients who are looking for a long lasting aesthetic solution. 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 Latin America. In those countries, Aquamid is used mainly for treating nasolabial folds, lip augmentation, cheek contouring, nose enhancement, and for treating facial lipoatrophy. More than a quarter of a million people have been treated with Aquamid. Aquamid is not yet approved for sale in the United States.

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This is the most recent date i've seen posted for Aquamid and it being close to FDA approval for USA. Do you see it coming soon?

Charlene BucinoJune 28, 2010




     

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