ZUG, SWITZERLAND -- Galderma announced that it has completed its European decentralized procedure (DCP), resulting in a positive decision for Relfydess (RelabotulinumtoxinA - previously referred to as QM1114). Relfydess is indicated for the temporary improvement in the appearance of moderate-to-severe glabellar lines (frown lines) at maximum frown and lateral canthal lines (crow’s feet) seen at maximum smile, alone or in combination, in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient.[9] Following the successful completion of the DCP, national approvals in the 16 concerned countries are now under finalization. Relfydess also received a marketing authorization in Australia earlier this year.

Relfydess is developed and manufactured by Galderma. It is the first and only ready-to-use liquid neuromodulator created with PEARL™ Technology that is designed to preserve molecule integrity to deliver a highly active, innovative, complex-free molecule, with up to 39% of patients seeing effects from day one and up to 75% of patients maintaining improvements for six months for frown lines and crow’s feet.[3,4,7,8] It is optimized for simple volumetric dosing, without reconstitution, to increase ease of use and help ensure consistent dose/volume.[1,10]

“With Relfydess, Galderma is introducing a highly differentiated and innovative neuromodulator, reinforcing our leadership and strong growth in this field, and our commitment to developing and delivering the broadest portfolio in Injectable Aesthetics. As per the decentralized European approach, our teams are now finalizing the approval procedures at the country level, so we’re ready to launch in multiple markets early next year.” FLEMMING ØRNSKOV, M.D., MPH, CHIEF EXECUTIVE OFFICER GALDERMA

This positive decision, and the previous Therapeutic Goods Administration approval in Australia, were based on results from the phase III READY (RElabotulinumtoxin Aesthetic Development StudY) clinical trial program, which enrolled more than 1,900 participants. Results showed:[3,4,7,8]

· Improvement in both frown lines and crow’s feet versus placebo:
- In READY-1 and READY-2, treatment with Relfydess demonstrated a 96.3% none-or-mild responder rate for frown lines and 87.2% for crow’s feet, after one month, vs 4.5% and 11.9% for placebo, respectively.

· Onset of action as soon as day one:
- In READY-1 and READY-2, 39% of patients reported improvements for frown lines and 34% reported improvements for crow’s feet from day one.

· Sustained results for six months:
- In READY-1 and READY-2, up to 75% of patients maintained improvements for six months.
- At month one, up to 96% achieved none-or-mild frown lines and crow’s feet, which was sustained for six months in almost a quarter of patients.

· Patient satisfaction was maintained for six months following treatment.

“With the growing need for new innovations in the neuromodulator space, I’m excited that, with Relfydess, we have a new treatment that delivers both fast and sustained results in a simple and convenient formulation, so we can achieve the desired outcomes for our patients quickly, effectively, and without compromise.” DR. SACHIN SHRIDHARANI LEAD INVESTIGATOR OF READY-1 TRIAL PLASTIC SURGEON AND FOUNDER OF LUXURGERY