Galderma's Relfydess™ (RelabotulinumtoxinA) Approved for Use in Europe

ZUG, Switzerland, July 30, 2024 - Galderma has successfully concluded its European decentralized procedure (DCP) for Relfydess™ (RelabotulinumtoxinA, previously known as QM1114), resulting in a favorable decision. Relfydess™ is designated for the temporary enhancement of moderate-to-severe glabellar lines (frown lines) at maximum frown and lateral canthal lines (crow’s feet) at maximum smile in adults under 65 years old, particularly when the severity of these lines impacts the patient psychologically.

Following the DCP's positive outcome, national approvals in the 16 involved European countries are nearing completion. Earlier this year, Relfydess™ also secured marketing authorization in Australia.

Relfydess™, developed and manufactured by Galderma, stands out as the first and only liquid neuromodulator ready for use, created with PEARL™ Technology. This technology is designed to maintain the integrity of the molecule, ensuring a highly active, innovative, and complex-free product. Notably, up to 39% of patients experience effects starting from day one, and up to 75% of patients sustain improvements for six months for both frown lines and crow’s feet. This product is optimized for simple volumetric dosing without the need for reconstitution, enhancing ease of use and consistency in dose and volume.

The successful decision and previous Therapeutic Goods Administration approval in Australia were grounded in findings from the phase III READY (RElabotulinumtoxin Aesthetic Development StudY) clinical trial program, which included over 1,900 participants. The trials demonstrated the safety, efficacy, rapid onset, and sustained effects of Relfydess™ over six months.

Regulatory submissions for Relfydess™ for treating frown lines and crow’s feet will continue to be assessed by additional global authorities.

About Relfydess™ (RelabotulinumtoxinA):
Pioneered by Galderma, Relfydess™ is distinguished as the first and only ready-to-use liquid neuromodulator created using PEARL™ Technology. This technology ensures the molecule's integrity, offering a highly active, innovative, and complex-free product. Up to 39% of patients notice effects from day one, and up to 75% maintain improvements for six months. Relfydess™ is optimized for easy volumetric dosing without reconstitution, ensuring consistent dose and volume each time. Developed and manufactured by Galderma, it aims to expand the company’s neuromodulator portfolio, which is part of the broadest Injectable Aesthetics portfolio available in the market.

About the READY clinical trial program:
The READY (RElabotulinumtoxin Aesthetic Development StudY) phase III clinical trial program encompasses four trials, which included more than 1,900 participants. These trials evaluated the safety, efficacy, rapid onset, and durability of Relfydess™' effects over six months.

About Galderma:
Galderma (SIX: GALD) is a leading pure-play dermatology company, operating in approximately 90 countries. It offers an innovative, science-based portfolio of premium brands and services across the entire dermatology market spectrum, including Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Since its founding in 1981, Galderma has dedicated itself to understanding and improving the human skin, the body's largest organ. The company partners with healthcare professionals to meet individual consumer and patient needs, delivering superior outcomes. Galderma’s mission is to advance dermatology for every skin story.