Approval Probability
TA Base Rate
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JUVÉDERM VOLBELLA XC injectable · 1 trial · 1 indication
The evaluating investigator assessed hollowing in both infraorbital areas using the 5-point photonumeric AIHS where: 0=none (no visible hollowing or volume loss medially or laterally), 1=minimal (presence of hollowing with some volume loss medial to the mid-pupillary line; smooth lateral lid-cheek transition), 2=moderate (defined hollowing extending laterally beyond the mid-pupillary line with moderate volume loss; smooth lateral lid-cheek transition with mild volume loss), 3=severe (defined hollowing extending laterally beyond the mid-pupillary line with moderate volume loss creating a defined groove along the lid-cheek junction), 4=extreme (defined hollowing extends from medial to lateral canthus; severe volume loss creates a marked step along the lid-cheek junction). The percentage of participants with at least a 1-point improvement change (decrease) in the AIHS is reported.
| Arm | Type | Description |
|---|---|---|
| JUVÉDERM VOLBELLA® XC | EXPERIMENTAL | JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator. Participants were eligible to receive an optional touch-up treatment 1 month later and an optional repeat treatment 12 months after last treatment, if applicable. A maximum of 2.2 milliliter (mL) per side was injected for initial and touch-up treatments combined. |
| No-treatment Control | NO_INTERVENTION | Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period. Participants were then eligible to receive optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area followed by an optional touch-up treatment 1 month later. |
| Name | Type | Description |
|---|---|---|
| JUVÉDERM VOLBELLA® XC injectable gel | DEVICE | JUVÉDERM® VOLBELLA™ XC dermal filler injected into the infraorbital and adjacent area. |
INCLUSION CRITERIA: * Age 22 or over and in good general health * Has "Moderate" or "Severe" infraorbital hollowing (grade 2 or 3 on the Allergan Infraorbital Hollows Scale (AIHS)) for each eye as assessed by the Evaluating Investigator (i.e., both eyes must qualify but do not need to have the same...
JUVÉDERM VOLBELLA XC injectable is used for the correction of infraorbital hollowing, which is the appearance of hollows or dark circles under the eyes. It is a hyaluronic acid (HA) injectable gel being developed by AbbVie Inc. for this aesthetic indication.
JUVÉDERM VOLBELLA XC injectable is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The product is part of the JUVÉDERM family of dermal fillers.
JUVÉDERM VOLBELLA XC injectable is in Phase 3 clinical development for infraorbital hollowing. It is an investigational product and has not been approved for this indication. One Phase 3 trial has been completed to evaluate its safety and effectiveness.
JUVÉDERM VOLBELLA XC injectable has one completed Phase 3 clinical trial, NCT03418545, titled "A Safety and Effectiveness of VOLBELLA XC Hyaluronic Acid (HA) Injectable Gel to Correct Infraorbital Hollowing." The trial enrolled 163 participants in the United States and was a randomized, no-treatment controlled study.
Yes, JUVÉDERM VOLBELLA XC injectable is also known as VOLBELLA XC. The clinical trial NCT03418545 refers to it as VOLBELLA XC Hyaluronic Acid (HA) Injectable Gel. It is a hyaluronic acid-based injectable gel being studied for infraorbital hollowing correction.