A Study to Evaluate the Safety and Efficacy of Revanesse Shape + With Lidocaine Versus Juvederm Voluma With Lidocaine for the Correction of Age-Related Midface Volume Deficit / Lipoatrophy at 6 and 12 Months Post-treatment

Inclusion Criteria:

1. Men or non-pregnant, non-breastfeeding women 22 years of age through 65 years of age.
2. Subjects seeking augmentation therapy for the mid-face with a MMVS score of 3 (moderate loss of fullness with slight hollowing) or 4 (substantial loss of fullnessin the mid-face area, clearly apparent hollowing) on each side of the face asindependently assessed by the blinded Evaluating Investigator and the unblindedTreating Investigator
3. If female and of childbearing potential, a negative urine pregnancy test at Baseline (Day 1) and the subject agrees to use adequate contraception during the study period.
4. Ability to understand and comply with the requirements of the study.
5. Willingness and ability to provide written informed consent.
6. Willing to abstain from any other facial procedures or treatments affecting facialvolume deficit at any time during the study

Exclusion Criteria:

1. MMVS score of 1 (fairly full) or 2 (mild loss of fullness) on either side of the face.
2. Women who are pregnant or lactating or anticipate becoming pregnant during the studyperiod.
3. Have ever undergone facial plastic surgery (with the exception of rhinoplasty morethan 2 years prior to enrollment), tissue grafting, or tissue augmentation withsilicone, fat, or other permanent (Ex: polymethylmethacrylate (Bellafill)), orsemi-permanent dermal fillers (Ex: calcium hydroxylapatite (Radiesse®)) or planning toundergo any of these procedures at any time during the study.
4. Have undergone temporary facial dermal filler injections with hyaluronic acid-basedfillers within 12 months, porcine-based collagen fillers within 12 months, orneuromodulator injections, mesotherapy, or resurfacing (laser, photomodulation,intense pulsed light, radio frequency, dermabrasion, chemical peel, microneedling orother ablative or non-ablative procedures) within 6 months on the face or neck priorto study entry or planning to undergo any of these procedures at any time during thestudy.
5. History of use of threads below the lower orbital rim within the preceding 6 months orplanning their use at any time during the study
6. History of use of injectable deoxycholate (Kybella®) anywhere on the face or neckwithin preceding 6 months or planning to undergo treatment at any time during thestudy
7. Evidence of scar-related disease or delayed healing activity to the mid-face withinthe past 1 year.
8. Has acute or chronic skin disease or scars at the intended treatment sites.
9. History of keloid formation or hypertrophic scars.
10. History or the presence of any disease that may result in changes in facial contour oredema of the face during the course of the study, (e.g., inflammation, infection,facial psoriasis, herpes zoster, acanthosis, cancer, pre-cancer, actinic keratosis,etc.)
11. Presence of active inflammatory process (skin eruptions such as cysts, pimples,rashes, or hives) or infection on the face.
12. Have severe malocclusion or dentofacial or maxillofacial deformities as judged by theTreating Investigator. Subjects planning to undergo extensive dental procedures suchas dental implants, multiple tooth extractions, or oral surgery should notparticipate. Minor dental procedures such as teeth cleaning and repair of caries arenot exclusionary.
13. Is on an ongoing regimen of anticoagulation therapy (e.g., warfarin), thrombolytics,or inhibitors of platelet aggregation
14. Nonsteroidal anti inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen) or othersubstances known to increase coagulation time (e.g., herbal supplements with garlic orgingko) within 10 days of undergoing study device injections. Subjects who willwithhold such therapy for 10 days before AND after any injection session mayparticipate.
15. Prescription, oral or topical anti-wrinkle products in the treatment area within 90days prior to treatment and throughout the study. (Use of sunscreens and continuedtherapy with OTC topical treatments (e.g., alpha hydroxyl acids, glycolic acids,retinoids) are allowed if regimen was established ≥ 90 days prior to treatment).
16. History of allergy, anaphylaxis or hypersensitivity to injectable hyaluronic acidproducts, local anesthetics of the amide type such as lidocaine, or gram positivebacterial proteins or is planning to undergo desensitization therapy during the study.
17. History or presence of multiple severe allergies or severe allergies manifested by ahistory of anaphylaxis.
18. History of known streptococcal disease.
19. Immunocompromised, immunosuppressed or current use of immunosuppressive therapy thatin the opinion of the investigator precludes participating in the trial.
20. Clinically significant organic disease including cardiovascular, hepatic, pulmonary,neurologic, or renal disease or other medical condition, serious intercurrent illness,or extenuating circumstance that, in the opinion of the investigator, precludesparticipation in the trial.
21. History or presence of porphyria
22. Have untreated epilepsy
23. History of connective tissue diseases such as rheumatoid arthritis, systemic lupuserythematosus, polymyositis (PM), dermatomyositis (DM) or scleroderma
24. Have bleeding disorders
25. Presence of wound on the face
26. Received any investigational product within 30 days of signing the ICF.
27. Facial tattoo that may interfere with MMVS evaluation.
28. Presence of facial hair that could interfere with MMVS evaluation. Subjects withfacial hair must agree to maintain the same style and length of facial hair throughoutthe duration of the study.
29. Systemic (oral/injectable) corticosteroids, anabolic steroids or immunosuppressivemedications within 30 days prior to treatment and topical steroids on the face within 14 days prior to treatment start and throughout the study.
30. Previous treatment for MVD within the past year.
31. History of malignancy within 5 years of study entry. Subjects with a history ofmalignancy that has been fully treated without evidence of recurrence for at leastfive years prior to study entry may participate. (Subjects with a history of basalcell carcinoma or squamous cell carcinoma outside of the treatment area that has beenfully removed by surgical means may participate at any time).
32. Currently has a cancerous or pre-cancerous lesion on the treatment area or has hadradiation exposure in the treatment area in the last 24 months.
33. The presence of any condition, which in the opinion of the investigator, that makesthe subject unable to complete the study per protocol (e.g., subjects not likely toavoid other facial cosmetic treatments, subjects not likely to stay in the studybecause of other commitments, concomitant conditions or past history; subjectsanticipated to be unreliable; or subjects who have a concomitant condition that mightconfuse or confound study treatments or assessments).
34. The intention to lose a significant amount of weight (more than 10 pounds) during thestudy.
35. Presence of moderate or severe abnormal rating for firmness or detection of anyabnormal mid-face structure, such as a scar or lump at baseline.
36. Presence of abnormal rating in mid-face function with inability to effectively puffcheeks, smile broadly, or chew at baseline.
37. Presence of abnormal rating in mid-face sensation with inability to feel 0.4Gmonofilament or cotton wisp at any site on the mid-face at baseline
38. Presence of abnormal vision assessments at baseline, e.g., Snellen Acuity Test worsethan 20/40 (with corrections, if applicable), abnormal confrontational visual fieldtest, or abnormal ocular motility test).