Juvéderm Voluma XC is a sterile, biodegradable, homogenous injectable gel implant containing hyaluronic acid produced by Streptococcus species of bacteria. The approval was based on data from a randomized, controlled multicenter clinical study (ClinicalTrials.gov Identifier: NCT04414397), which assessed the efficacy and safety of Juvéderm Voluma XC for correction of temple hollowing.

During the primary phase of the study, participants were randomly assigned to either a treatment group (n=112) or to a no-treatment control group (n=58). Touch-up treatments occurred approximately 30 days after initial injection, if needed. 

After the 3-month blinded “no treatment” control period, control patients were offered Juvéderm Voluma XC; 53 participants elected to receive treatment. A total of 40 treatment-group participants opted for the optional maintenance treatment, which was offered to the treatment group 13 months after the last treatment.

At 3 months, findings showed 80.4% of patients treated with Juvéderm Voluma XC achieved at least a 1-point improvement in moderate to severe temple hollowing using the Allergan Temple Hollowing Scale. The responder rate for the treatment group was significantly greater than the control group (difference of 66.9%; P <.0001). Juvéderm Voluma XC provided immediate improvement in moderate to severe temple hollowing that lasted for more than 1 year (responder rate for the treatment group at 13-month follow-up: 73.3%). 

Using the FACE-Q Satisfaction with Facial Appearance questionnaire, patients treated with Juvéderm Voluma XC reported the following:

• More than 85% were satisfied with how balanced, well-proportioned, and symmetric their face looked after 3 months;
• Sixty-eight percent were satisfied with how fresh their face looked;
• Seventy-two point seven percent were satisfied with how rested their face appeared after 3 months; and
• Upwards of 80% were satisfied with how youthful their temples made them look and how well the shape of their temples complemented the shape of their face after 3 months.

“The approval of Juvéderm Voluma XC to treat temple hollows further demonstrates Allergan Aesthetics commitment to innovation and addressing patient needs,” said Carrie Strom, President, Allergan Aesthetics and Senior Vice President, AbbVie. “This is the first US FDA approval of a hyaluronic acid dermal filler for use in the upper face and addresses a real unmet need for patients.”

Juvéderm Voluma XC is also indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume loss in the mid-face, and for augmentation of the chin region to improve the chin profile.

As of April 12, 2024, 19 people have reported significant side effects linked to counterfeit Botox products or mishandled botulinum toxin in 9 states (Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, and Washington). These adverse events included blurred or double vision, drooping eyelids, difficulty swallowing, dry mouth, slurred speech, constipation, incontinence, shortness of breath, generalized weakness and difficulty lifting one’s head.

Of these 19 patients, 9 were hospitalized and 4 were treated with botulism antitoxin due to concerns over possible spread of botulinum toxin to other parts of the body. All of the affected individuals were females who received the injections in non-health care settings by untrained individuals who purchased the product from unlicensed sources.

The investigation, which includes the Centers for Disease Control and Prevention (CDC), state health departments, and manufacturers, is ongoing. At this time, health care providers are being asked to carefully inspect their product for any signs of counterfeiting before use. The FDA is working with AbbVie, the manufacturer of Botox, to identify and remove suspected counterfeit products from the US drug supply.

The authentic product includes the following features:

• Product descriptions on the outer cartons are either “BOTOX^® COSMETIC / onabotulinumtoxinA / for Injection” or “OnabotulinumtoxinA / BOTOX^® / for injection”;
• Manufacturer identified on outer carton as either “Allergan Aesthetics / An AbbVie Company” or “abbvie”;
• Outer carton and vial both display the active ingredient as “OnabotulinumtoxinA”; and
• Available in 50-, 100-, and 200-unit dose forms.

The counterfeit product can be identified by 1 or more of the following:

• Outer carton and vial contain lot number C3709C3;
• Outer carton displays the active ingredient as “Botulinum Toxin Type A”;
• Outer carton and vial indicate 150-unit doses; and
• Outer carton contains language that is not in English.

Health care providers who suspect systemic botulism should call their health department immediately for consultation and antitoxin release. Additionally, the CDC’s clinical botulism service can be reached at 770-488-7100.

Adverse events related to medication use should be reported to the FDA’s MedWatch program. Consumers who suspect they were administered counterfeit Botox should call the FDA at 800-551-3989 or submit the report here. 

Letybo is an acetylcholine release inhibitor and a neuromuscular blocking agent. The approval was based on data from 3 identical, randomized, double-blind, placebo-controlled phase 3 trials (ClinicalTrials.gov Identifier: BLESS I [NCT02677298], BLESS II [NCT02677805] and BLESS III [NCT03985982]), which evaluated the efficacy and safety of Letybo for use in the temporary improvement of the appearance of moderate to severe glabellar facial lines. 

The trials included adults (age range, 19 to 75 years) with glabellar lines of at least moderate severity at maximum frown (severity score of 2 or 3 on Facial Wrinkle Scale). Patients were excluded if they had ptosis, deep dermal scarring or an inability to substantially lessen glabellar lines even by physically spreading the glabellar lines apart. 

Study participants were randomly assigned 3:1 to receive a single treatment of Letybo (n=957) or placebo (n=319). The primary endpoint was treatment success at week 4, defined as the proportion of patients achieving a score of 0 or 1 and an improvement of at least 2 points from baseline at maximum frown as assessed by using the Glabellar Line Scale.

Results showed a greater proportion of patients who received Letybo achieved treatment success compared with placebo (treatment difference: 47% [95% CI, 43%-51%] in BLESS I; 45% [95% CI, 36%-54%] in BLESS II; and 65% [95% CI, 59%-71%] in BLESS III). 

As with other botulinum toxin products, the prescribing information for Letybo includes a Boxed Warning regarding distant spread of toxin effect. The most common adverse reaction reported in clinical trials was headache (2%). 

Letybo is supplied in a single-dose vial containing either 50 Units/vial or 100 Units/vial. The potency units of Letybo are not interchangeable with other preparations of botulinum toxin products.

Letybo is expected to be available in the second half of 2024.