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6/16/2010 Aquamid Submitted for FDA Approval
Contura International A/S, Soeborg, Denmark, last week announced that it has submitted a Premarket Approval Application (PMA) for Aquamid to the FDA requesting marketing approval in the United States for the aesthetic treatment of moderate to severe facial wrinkles and folds. Aquamid Submitted for FDA Approval
A soft volume filler, Aquamid is the trade name for a specific formulation of hydrophilic polyacrylamide gel.
The application includes a successful US-based 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 end points, 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 2 years and demonstrated a consistent effectiveness and safety profile.
Marketing and use of Aquamid was recently approved by European authorities.
