Mid-Face Volume Study

Inclusions:

• Male or female, the participant must be 18 or older at the time of signing the ICF
• Participants seeking soft tissue augmentation in the mid-face

Exclusions:

• Has experienced trauma to the face within 6 months before enrollment or has residual deficiencies, deformities, or scarring
• Active or recurrent inflammation or infection in either eye
•  Tendency to develop hypertrophic scarring and/or keloid scarring
• Active autoimmune disease
• Current cutaneous or mucosal inflammatory or infectious processes (eg, acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion, in the face
• Fat injection or permanent facial implants (eg, polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere on the face
•  Temporary dermal filler injections in the face within 24 months before enrollment, semi-permanent fillers, or permanent facial implants (eg, poly-L-lactic acid, CaHA polymethylmethacrylate) anywhere in the face within 36 months before enrollment
• Had botulinum toxin treatment in the cheek area (including crow’s feet) within 6 months before enrollment
•  Had mesotherapy or cosmetic facial procedures on the face within 6 months before enrollment. Examples of mesotherapy or cosmetic facial procedures are face-lift, laser, photomodulation, intense pulsed light, radio frequency dermabrasion, moderate or greater depth chemical peel, or other ablative procedures
• Tattoos, piercings, facial hair, or scars on the face that would interfere with the visualization of the face for the effectiveness assessment
•  Undergone a dental procedure within 6 weeks before treatment or plan to undergo a dental procedure (other than prophylaxis or dental fillings) during the course of the study
•  History of an allergic reaction or significant sensitivity to constituents of the study
• Females who are pregnant, planning a pregnancy, or nursing.