Vascular occlusion causing blindness is a rare yet greatly feared complication of the use of facial aesthetic fillers. The authors performed a review of the aesthetic literature to ascertain the reported cases of blindness and the literature reporting variations in the vascular anatomy of the human face. The authors suggest a small but potentially helpful addition to the accepted management of the acute case. Cases of blindness, mostly irreversible, from aesthetic filler injections have been reported from Asia, Europe, and North America. Autologous fat appears to be the most frequent filler causing blindness. Some cases of partial visual recovery have been reported with hyaluronic acid and calcium hydroxylapatite fillers. The sudden profusion of new medical and nonmedical aesthetic filler injectors raises a new cause for alarm about patient safety. The published reports in the medical literature are made by experienced aesthetic surgeons and thus the actual incidence may be even higher. Also, newer injectors may not be aware of the variations in the pattern of facial vascular arborization. The authors present a summary of the relevant literature to date and a suggested helpful addition to the protocols for urgent management.

No abstract

Background: DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A formulation in clinical development. A phase 2 dose-ranging study identified an optimal dose and demonstrated efficacy with a median duration of 24 weeks. Methods: In two phase 3, multicenter, randomized, double-blind, placebo-controlled studies (SAKURA 1 and SAKURA 2), subjects with moderate or severe glabellar lines at maximum frown were assigned randomly to receive placebo or 40 U of DAXI. Glabellar lines were evaluated at least every 4 weeks for at least 24 weeks until severity returned to baseline (≤36 weeks). Results: Overall, 609 subjects were enrolled (DAXI, n = 405; placebo, n = 204). DAXI was significantly more effective than placebo in achieving the primary efficacy outcome (≥2-point improvement in glabellar line severity at maximum frown at week 4 according to both investigator and subject ratings): 73.6 percent versus 0.0 percent (SAKURA 1), and 74.0 percent versus 1.0 percent (SAKURA 2) (both p < 0.0001). Composite investigator and subject ratings of maximum frown after DAXI treatment showed that glabellar line severity of none or mild was maintained for a median of 24.0 weeks (SAKURA 1) and 23.9 weeks (SAKURA 2), and glabellar line severity did not return to baseline levels for a median of 27.7 and 26.0 weeks, respectively. DAXI was generally well tolerated, with the most common adverse events related to DAXI treatment being headache (SAKURA 1, 7.0 percent; SAKURA 2, 5.9 percent) and injection-site pain (5.0 percent and 2.4 percent, respectively). Conclusions: Results from both studies were highly consistent. DAXI may offer a prolonged duration of response (median, ≥24 weeks) and is generally well tolerated. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Background Rejuvenation of the under-eye area is a popular facial aesthetic treatment option. Objectives This study evaluated the safety and effectiveness of VYC-15L for the correction of moderate or severe infraorbital hollowing. Methods This was a randomized, controlled, single-blind study with a primary endpoint defined as the proportion of participants with ≥ 1-grade improvement at Month 3 assessed by an evaluating investigator (EI) using the Allergan Infraorbital Hollows Scale (AIHS). Three-dimensional imaging was conducted to assess infraorbital volume up to Month 12. Procedure pain and injection-site responses (ISRs) were documented, and safety was monitored throughout the study. Results At month 3, the difference between treatment (83.1%) and control (15.6%) was 67.5% (95% CI 52.9 - 82.0, p &lt; 0.0001). 3D imaging showed a mean volume increase from baseline of 0.733 mL (left) and 0.777 mL (right) at Month 12. Mean pain scores were &lt; 1.7 (scale of 0 to 10). Most ISRs with initial treatment were mild/moderate and resolved in &lt; 1 week, including tenderness (49.5%), bruising (42.7%), and swelling (41.7%). Thirty-four participants had treatment-emergent adverse events (TEAEs), of which 14 (10.3%) had treatment-related TEAEs, including bruising (3.8%) and swelling/edema (2.9%), which resolved in &lt; 2 weeks. Three participants had swelling/edema starting &gt; 30 days post-treatment; 2 resolved in &lt; 4 days, 1 by 45 days. No treatment-related serious adverse events were reported. Conclusions VYC-15 was safe and effective for the correction of moderate or severe infraorbital hollowing and lasted through 1 year.