Real-World Evidence on the Routine Use, Efficacy, and Safety of a Hyaluronic Acid-Based Dermal Filler in the Periorbital Region.

[BACKGROUND] The appearance of the periorbital region is essential in facial aesthetic perception and is a frequent concern of patients seeking rejuvenation. TEOSYAL® PureSense Redensity 2 (R2) has a 10-year track record of effectively and safely treating the under-eye area, specifically the tear trough.

[METHODS] A prospective, observational study aimed to investigate the efficacy and safety of R2 in a real-world setting for aesthetic indications. Participants received at least one treatment injection with R2, and investigators followed their routine injection techniques and indications. The primary endpoint was the Global Aesthetic Improvement Scale (GAIS) score recorded 3 months post-injection. Secondary efficacy outcomes included subject and investigator satisfaction, as well as GAIS scores at later timepoints. Safety was monitored by documenting common treatment responses (CTRs) and adverse events (AEs).

[RESULTS] The 136 subjects enrolled in EYELIGHT received 958 initial injections, of which 451 (47.1%) were performed with R2: 89 (35.3%) tear trough, 61 (24.2%) palpebromalar groove, 45 (17.9%) outer canthus, 38 (15.1%) crow's feet, and 19 (7.5%) brow. A GAIS improvement of more than 70% was achieved for the tear trough and remaining periorbital indications, with most subjects reporting satisfaction with treatment (84.3%). Treatment effect was observed up to 12 months post-injection. All CTRs were mild or moderate and resolved within a month. No severe AEs were reported.

[CONCLUSION] Real-world evidence confirmed the 10-year long success of R2 as an effective and safe treatment of the tear trough. Based on this evidence, its use extends beyond the tear trough, showing effectiveness and safety in the whole periorbital area.

[LEVEL OF EVIDENCE III] This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .