Contura Inc. has submitted a Premarket Approval Application (PMA) for 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.