Radiesse injectable approved for new indication

In the EU, Merz Aesthetics has announced the approval for Radiesse to treat the décolleté area. 

This approval stems from positive study results demonstrating the effectiveness and safety of Radiesse for the treatment of décolleté wrinkles.

The study had a duration of 52 weeks, with 117 subjects aged 18-65 years of age, who presented with moderate to severe wrinkles in the décolleté.

Radiesse proved a clinically and statistically significant improvement in décolleté wrinkles and overall satisfaction, with 73.5% of the treated subjects achieving at least a 1-point improvement on the MAS décolleté wrinkles-at-rest scale, 16 weeks after last treatment.

This positive finding was confirmed by the secondary effectiveness endpoints including further investigator and patient-reported outcomes.

No treatment-related serious adverse events (AEs) occurred. The most common treatment-related AEs were injection site reactions (bruising, erythema, swelling, pain, nodule) and were mild, transient (duration of less than 14 days) and resolved without sequelae.

"Despite being one of the most visible areas of our bodies, the décolleté area is often overlooked when it comes to aesthetics" says Dr Samantha Kerr, chief scientific officer at Merz Aesthetics. "Radiesse presents a unique solution to improving décolleté wrinkles and provides our customers and their patients a non-surgical, effective option to address ageing décolleté skin.”

Dr Tatjana Pavicic, who was part of the clinical study, says: "We know that patients are looking for treatment options that are minimally invasive, this launch not only expands the scope of Radiesse but also showcases a new era of aesthetic procedures, empowering patients to feel their best. Our findings speak for themselves and demonstrate the possibility of what this new indication could achieve for patients who are looking to improve the overall appearance of décolleté wrinkles."

Gonzalo Mibelli is the Europe, Middle East, and Africa (EMEA) president of Merz Aesthetics. He thinks the launch reflects patient need.

There has been a significant shift toward regenerative biostimulation as a preferred method of aesthetic treatment for patients. Google Trends data further support this showcasing a continual surge in searches for ‘collagen’ between 2016-2022, confirming a shift in aesthetic preferences for patients.

"Our data showcases Radiesse's effectiveness in reducing décolleté wrinkles. This launch also reflects a broader shift towards minimally invasive procedures driven by patients' evolving preferences for enhancing their body's anti-ageing processes for aesthetic improvements."

 He continues, "The launch of the Radiesse décolleté indication is an exciting time for Merz Aesthetics. We can see that while there is a steady rise in the number of patients seeking an immediate lift to smooth wrinkles in the décolleté area, patients equally want more healthy-looking results and improved skin quality.”