Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® S in the Correction of Moderate or Severe Infraorbital Hollowing

Inclusion criteria

• Signed informed consent by the subject
• Females and males ≥ 22 years of age
• Has "Moderate" or "Severe" infraorbital hollowing (grade 2 or 3 on the AIHS) on the 5-point AIHS for each eye as assessed by the Evaluating Investigator (i.e., both eyes must qualify but do not need to have the same score)
• Ability to follow study instructions and likely to complete all required visits
• Reliable methods of contraception which result in a low failure rate (i.e. less than 1 % per year) for women of childbearing potential, e.g. implants, injectables, combined oral contraceptives, some intrauterine-devices, sexual abstinence or vasectomized partner) for the entire study duration.

Exclusion criteria

• Has hyperpigmentation in the infraorbital area (does not include dark circles under the eyes, not due to hyperpigmentation).
• Has ever received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted with any of these products during the study
• Has ever undergone fat injections above the subnasale or is planning to undergo this procedure during the study
• Has tattoos, piercings, facial hair (i.e., beard, moustache), or scars that would interfere with visual assessment of the infraorbital hollows
• Has undergone volume augmentation with semi-permanent dermal fillers (e.g., calcium hydroxyapatite, poly-L-lactic acid) or temporary dermal fillers in the malar area, temples, or around the eyes within 12 months before enrolment or is planning to undergo such treatment during the study
• Using any new over-the-counter or prescription oral or topical, anti-wrinkle products within 30 days before enrolment or is planning to begin using such products during the study. Subjects who have been on a regimen of such products for at least 30 days are eligible for the study if they intend to continue their regimen throughout the study)
• Has congenital or acquired deformities of theface, lipodystrophy, or poor nutritional status
• Has active or recurrent inflammation or infection in either eye
• History of or active autoimmune disease/immune deficiency
• Taking medications and/or substances known to increase coagulation time (e.g., aspirin, ibuprofen, or herbal supplements) 10 days prior to treatment
• Simultaneousness with laser therapy or deep chemical peeling
• Prone to hypertrophic scars
• History of allergy to hyaluronic acid or any of the product's components
• History of allergy to lidocaine or local anaesthesia of amide compounds
• Known case of porphyria
• Pregnancy or lactation
• Have a condition or be in a situation that, in the physician's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
• Untreated epilepsy
• Hypersensitivity to gram positive bacterial proteins as hyaluronic acid is produced by Streptococcus type bacteria