Pivotal phase 3 data highlights efficacy and safety in anticipation of U.S. Food and Drug Administration (FDA) review and global post-market analysis reports on safety data collected from more than 2,000 patients

New Orleans, La. – (November 10, 2016) – 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, doubleblinded, 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 Safety data were collected from published and unpublished post-market studies of more than 2,000 patients worldwide from 2011 to 2015.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:

About Galderma

Dating back to 1961, Galderma is now present in 100 countries with an extensive product portfolio 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® (abobotulinumtoxinA) and Sculptra® Aesthetic.

For more information, please visit www.galderma.com and www.galdermausa.com.

All trademarks are the property of their respective owners.

Contacts:

Virginie Naigeon,

Communications Director,

Galderma North America;

virginie.naigeon@galderma.com

Amir Khan

Marina Maher Communications

akkhan@mahercomm.com

¹ Restylane Refyne and Restylane Defyne, were first approved outside of the U.S. in 2010 under the brand name Emervel.