Key findings from the KYBELLA® clinical trials include:1
- KYBELLA® achieved all primary and secondary efficacy endpoints in the reduction of submental fullness with a high degree of statistical significance (p<0.001)
- 68.2% of patients treated with KYBELLA® were ≥1-grade composite responders compared to 20.5% of placebo treated patients based upon validated physician and patient measurements
- 16% of patients experienced a ≥2-grade improvement with KYBELLA®, compared to 2% of patients who responded to placebo, based on validated physician and patient measurements
- KYBELLA® treatment resulted in high patient satisfaction – 79% of KYBELLA®-treated patients reported satisfaction with their appearance in association with their face and chin
- Marginal mandibular nerve (MMN) injury occurred in 4% of subjects. To avoid the potential for nerve injury, do not inject KYBELLA® into or in close proximity to the marginal mandibular branch of the facial nerve. Dysphagia occurred in 2% of subjects. Avoid use of KYBELLA® in patients with a current or prior history of dysphagia as treatment may exacerbate the condition. Bruising occurred in 72% of subjects. KYBELLA® should be used with caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy.
- The most common adverse reactions were edema/swelling, hematoma/bruising, pain, numbness, erythema and induration
See detailed Important Safety Information here.