A round-up of news stories in the aesthetic and anti-ageing medicine industry

GALDERMA RECEIVES FDA APPROVAL FOR ITS LATEST HA FILLER — RESTYLANE® EYELIGHT

AIMS TO IMPROVE THE APPEARANCE OF UNDEREYE HOLLOWS FOR UP TO 18 MONTHS

Galderma has announced the U.S. Food and Drug Administration (FDA) approved Restylane® Eyelight for the treatment of undereye hollows, also known as dark shadows, in adults over the age of 21. Restylane Eyelight, an undereye hyaluronic acid (HA) dermal filler, is the first and only product in the U.S. formulated with NASHA® Technology for volume loss under the eyes, giving patients natural-looking results.

For millions of Americans, dark circles can make individuals feel older, tired and stressed. Dr. Carolyn Jacob, a board-certified dermatologist based in Chicago and a lead investigator in the clinical trial of Restylane Eyelight sees first-hand how undereye concerns are top of mind for consumers.

‘Many of my patients seek treatment for hollows under the eyes, and topical products such as creams, concealers and undereye masks just aren’t able to solve the problem and provide the long-lasting results they are seeking. I’m pleased to see that Restylane Eyelight offers a safe, effective and natural- looking outcome that enables my patients to achieve their aesthetic undereye goals, with results that last up to 18 months with optimal treatment.’ Said Dr Jacob.

This FDA approval is supported by efficacy and safety data from a randomised, evaluatorblinded, parallel group, no-treatment controlled, multi-centre Phase 3 study to evaluate the effectiveness and safety of Restylane Eyelight for correction of volume loss under the eyes.

Lack of volume and volume loss in the undereye region can create shadows and emphasise dark circles, leading to the appearance of tiredness and/or ageing. In the Phase 3 study, 87% of patients had reduced undereye hollowness at 3 months, and Restylane Eyelight was found to be well tolerated under the eyes. At 3 months, 92% of patients were pleased with their results, and 84% were still pleased through 1 year. The study also yielded high satisfaction, with 93% of patients expressing interest in receiving treatment again after 12 months.

Restylane’s legacy with safety continues with this Phase 3 trial where most patients (87%) did not experience adverse events related to treatment with Restylane Eyelight.

The most commonly observed side effects for undereye injection are swelling, redness, tenderness, pain, bruising, itching, and lumps or bumps at the injection site. Most adverse events were mild in severity (75%) and none were severe. There was no incidence of Tyndall effect (blue discolouration) after treatment with Restylane Eyelight.

Espras Calls For Specialist Training Standard Across Europe

The European society that represents all national associations in plastic surgery across Europe has issued a call-to-action for a comprehensive approach to protect patients from under-trained ‘beauty surgeons’, some of whom are not certified plastic surgeons and only trained in special regions of the body or not trained in surgery at all.

The European Society of Plastic, Reconstructive and Aesthetic Surgery (ESPRAS) ensures that all member plastic surgeons have advanced multi-year training in plastic surgery, however, in most European countries there is no law to stop medical doctors without specialisation calling themselves ‘aesthetic surgeons’ or ‘beauty doctors.’ Shockingly, often even paramedics can take on these titles with just basic knowledge acquired over weekend courses or short plastic surgery attachments. On the flip side, board-certified surgeons meet the highest degree of qualification; have multi-year specialisation, work rotations in ICU and emergency care, undertake research and teaching, are required to demonstrate a catalogue of operations, and sit a final exam.

ESPRAS conducted a survey across 23 European countries to assess levels of education/ specialisation in plastic surgery. The results demonstrated a high level of training required for board certification, further driving home the need for the public to be made aware of the dangers of opting for a practitioner who is not trained to this standard. Such a move is the first step to ensuring quality of training, with patient safety taking precedence over financial gain, ESPRAS claims in its position paper. ESPRAS is working to support national legislation to provide clear regulation of aesthetic surgery Europe-wide.