A Pilot Study to Assess the Effectiveness and Safety of Belotero Balance® Injection for Volume Augmentation of the Infraorbital Hollow

Inclusion Criteria:

- Has right and left IOH volume deficit with a rating of 2 or 3 (moderate or severe) on
the MIHAS, as determined by the blinded evaluator. The treating investigator must
agree that the subject meets this criterion of a 2 or 3 rating on the MIHAS.

- Has the same MIHAS score on both IOHs (i.e., IOHs are symmetrical).

- Is at least 22 years of age.

- Understands and accepts the obligation not to receive any other procedures (i.e.,
dermal fillers, toxin treatments, facial ablative or fractional laser, microderm
abrasion, chemical peels, non-invasive skin-tightening [e.g., Ultherapy, Thermage] and
surgical procedures) in the face during participation in the study.

Exclusion Criteria:

- Prior lower-eyelid surgery, including orbital or midface surgery, or has a permanent
implant or graft in the midfacial region that could interfere with effectiveness
assessments or plans to have it during the study.

- Has gained or lost ≥ 2 body mass index (BMI) units within the previous 90 days or has
the intention to gain or lose a significant amount of weight during the first 90 days
of the study.

- Ever been treated with fat injections or permanent and/or semi-permanent dermal
fillers in the midfacial region or plans to receive such treatments during
participation in the study.

- Received lower eyelid and/or malar region treatments with any absorbable or temporary
fillers such as porcine-based collagen fillers, hyaluronic acid (HA) products,
RADIESSE®, poly L-lactic acid (PLLA) or received mesotherapy treatment to the area
within the past 24 months or plans to receive such treatments during participation in
the study.

- Any current or history of uncontrolled retinal disease or detached retina or any other
condition with the potential to cause a decline of visual acuity (e.g., uncontrolled
diabetes).

- Received deep facial dermal therapies (i.e., facial ablative or fractional laser, deep
chemical peels, non-invasive skin-tightening [e.g., Ultherapy, Thermage]) to the
periorbital or malar region within the past 12 months or plans to receive such
treatment during participation in the study.

- Received superficial facial dermal therapies (i.e., microderm abrasion, superficial
chemical peels) to the periorbital or malar region within the past 6 months or plans
to receive such treatment during participation in the study.

- Received toxin treatment to the periorbital region within the past 6 months or plans
to receive such treatment during participation in the study.

- Received immunosuppressive medications or systemic steroids (except intranasal/inhaled
steroids) in the past 2 months or plans to receive them during participation in the
study.

- Tendency to accumulate fluid in the lower eyelids, has developed festoons, or has
large and/or herniating infraorbital fat pads.

- Lower lid retraction, significant prominent eyes, or severe negative facial vector.

- Dark circles under the eyes due to pigmentation changes and not from infraorbital
hollow shadowing.

- Ectropium, entropion, or trichiasis of the lower eyelid or eye diseases that lead to
reddening and tendency of watering of the eye.

- Active or a history of recurrent or chronic infraorbital edema or rosacea or
uncontrolled severe seasonal allergies.

- A history of allergic/anaphylactic reactions, including hypersensitivity to lidocaine
or anesthetics of the amide type, hyaluronic acid preparations, gram positive
bacterial proteins, or any of the device components.

- A known bleeding disorder or has received or is planning to receive anti-coagulation,
anti-platelet, or thrombolytic medications (e.g., warfarin), anti-inflammatory drugs
(e.g., aspirin, ibuprofen), or other substances known to increase coagulation time
(vitamins or herbal supplements, e.g., vitamin E, garlic, gingko), from 10 days before
to 3 days after injection.

- Any other medical condition with the potential to interfere with the study outcome
assessments or compromise subject safety (e.g., increase the risk of AEs).