NEW ORLEANS, Nov. 10, 2016 /PRNewswire/ -- Galderma, a global leader focused on medical solutions in skin health, will share data from two pivotal Phase 3 clinical studies investigating Restylane® Refyne and Restylane® Defyne at the 2016 American Society for Dermatologic Surgery (ASDS) Annual Meeting, on November 10-13 in New Orleans. The multi-center, double-blinded, randomized, active-controlled studies evaluated the safety and efficacy of Restylane® Refyne and Restylane® Defyne. The data from these studies support Galderma's submission for FDA review for a new hyaluronic acid dermal filler technology.
The ASDS Annual Meeting program will also include an abstract of the Emervel®1 global safety database. Safety data were collected from published and unpublished post-market studies of more than 2,000 patients worldwide from 2011 to 2015. These results seek to provide a proven track record of safety for subjects treated with Restylane® Refyne and Restylane® Defyne.
"We are very excited to share the results of our pivotal studies around the Restylane® Refyne and Restylane® Defyne dermal fillers," said Philip M. Brown, MD, JD, Senior Vice President of Medical and Regulatory Affairs, Galderma, U.S. "At Galderma, we seek to address the needs of our consumers with scientifically-proven, innovative products. We look forward to the potential launch of these two scientifically advanced gels that will complement the Restylane line of products currently used around the world, with over 28 million treatments and counting.
Galderma looks forward to sharing additional data at the Meeting, including:
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Title |
Author |
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POSTER: OBT-HAECL versus HYL-HAJU for the Treatment of Moderate-to-Severe Nasolabial Folds: A Phase 3, Randomized, Evaluator-blinded Study |
Gary Monheit, MD (presenter); Steven Fagien, MD; Derek H. Jones, MD; David E. Bank, MD; Neil Sadick, MD; Alessandra Nogueira, MD; Jay Mashburn, PhD |
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POSTER: A Randomized, Evaluator-blinded, Phase 3 Study Comparing OBT-HAEDL Versus HYL-HAJUP in the Treatment of Moderate-to-Severe Nasolabial Folds |
Robert Weiss, MD (presenter); Steven Grekin, DO; Rhoda Narins, MD; Michael Gold, MD; Alessandra Nogueira, MD; Jay Mashburn, PhD |
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ASDS PROGRAM (ABSTRACT): A Comprehensive Analysis of the Safety of a New Range of Injectable Hyaluronic Acid Products for Aesthetic Indications |
David E. Bank, MD; Derek H. Jones, MD; Cindy Wong, MD |
About Galderma
Created in 1981, Galderma is now present in over 100 countries with an extensive product portfolio of medical solutions to treat a range of dermatological conditions. The company partners with health care professionals around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin, hair and nails.
Strategic brands in the U.S. include Epiduo® Gel, Epiduo® Forte Gel, Oracea® Capsules, Clobex® Spray, Differin® Gel, Mirvaso® Gel, MetroGel® Gel, Soolantra® Cream, Vectical® Cream, Tri-Luma® Cream, Cetaphil®, Benzac® Acne Solutions, Restylane®, Restylane® Silk, Restylane® Lyft, Dysport® and Sculptra® Aesthetic.
For more information, please visit www.galdermausa.com and www.galderma.com.
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1 Restylane Refyne and Restylane Defyne, were first approved outside of the U.S. in 2010 under the brand name Emervel.
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SOURCE Galderma