RHA Redensity Eye FDA Approval: Fourth On-Label Under-Eye HA, Not the First

If your cosmetic injector or med spa announced a "brand-new, revolutionary under-eye filler" approved in August 2026 as the first hyaluronic acid (HA) engineered specifically for tear troughs, they are repeating a commercial press release rather than reading the regulatory record.

The product is RHA Redensity Eye, manufactured by Teoxane S.A. in Geneva, Switzerland, and distributed in the United States by Revance Aesthetics. While its commercial availability was publicly announced on August 20, 2026, the official regulatory action occurred months earlier under Premarket Approval (PMA) supplement P170002/S050, approved by the United States Food and Drug Administration (FDA) on May 12, 2026.

Most importantly, RHA Redensity Eye is the fourth FDA-approved hyaluronic acid filler for infraorbital hollows in the United States—not the first.

Before booking a tear-trough treatment with this new gel, every patient should understand its exact formulation, how its clinical trial endpoints differ from promotional headlines, how it compares to incumbent under-eye fillers, and which aesthetic problems it cannot solve:

1. Fourth On-Label Under-Eye HA: Three hyaluronic acid fillers already held on-label FDA indications for infraorbital hollows before Redensity Eye's approval: Juvéderm Volbella XC (approved May 2021), Restylane Eyelight (approved May 2023), and Belotero Balance (+) (approved September 2023).
2. A Distinct 15 mg/g Formulation: RHA Redensity Eye is a 15 mg/g crosslinked sodium hyaluronate gel. It is chemically distinct from perioral RHA Redensity (a 23 mg/mL gel FDA-approved in 2021 for lipstick lines and perioral rhytids) and is not the same as European Teosyal Redensity 1 (a non-crosslinked skin booster not approved in the US).
3. Two Approved Syringe SKUs: The FDA approval covers two presentations: RHA Redensity Eye Lido (with 0.3% lidocaine, packaged with two 30G needles and a 36-month shelf life) and RHA Redensity Eye (with 0.3% mepivacaine, packaged with one 30G needle and a 25G 1.5-inch cannula, with a 24-month shelf life).
4. Endpoint Discipline (79% vs. 93%): The 93% "aesthetic improvement" figure circulating in promotional materials is a secondary blinded-evaluator Global Aesthetic Improvement Scale (BLE GAIS) result in a pooled treated set at week 12. The actual co-primary on the validated Teoxane Infraorbital Hollows Scale (TIOHS) was a 79.0% response rate in treated patients versus 9.8% in untreated controls.
5. Mandatory Injector Training: Because the infraorbital region borders terminal branches of the ophthalmic artery and carries devastating vascular occlusion risks, the FDA's May 12 approval order legally restricts product distribution to healthcare providers who complete a mandatory device-specific periocular training program.
6. Hollows vs. Bags vs. Pigment: RHA Redensity Eye is indicated strictly for moderate to severe structural volume loss in adults aged 22 and older. It cannot dissolve fat bags, tighten loose eyelid skin, or lighten melanin hyperpigmentation.

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Direct Answer: What Did the FDA Actually Approve?

For a patient evaluating RHA Redensity Eye for under-eye hollows:

• Regulatory identity: FDA PMA supplement P170002/S050 (Panel Track review, product code LMH, Class III medical device) approved on May 12, 2026 for Teoxane S.A., with commercial rollout initiated by Revance on August 20, 2026.
• Approved indication: Injection into the sub-dermis and supraperiosteum for the correction of moderate to severe tissue volume deficiencies in the infraorbital region in adults aged 22 years or older.
• Clinical trial performance: In pivotal study NCT04577898 (n = 248 actual; 183 treated vs. 65 control in Phase 1a), 79.0% of treated patients achieved a ≥ 1-grade improvement in both eyes on the blinded TIOHS scale at 12 weeks, compared to 9.8% of controls. Patient-reported satisfaction (modified FACE-Q lower eyelid score) improved by +37.5 points versus −4.1 in controls.
• Volume delivered: The trial administered a mean initial volume of 1.52 mL across both eyes (~0.76 mL per eye), capped at 1.0 mL per eye with no touch-ups permitted during the primary evaluation window.
• Safety signals: In the trial cohort, Tyndall effect (bluish discoloration under thin eyelid skin) occurred in 2.8% (7 of 248), all mild. Zero device-related vascular occlusions and zero granulomas were observed in the study cohort.
• Who should skip: Anyone with prominent herniated orbital fat pads (eye bags), true skin festoons, or pigmentary dark circles; individuals with histories of severe anaphylaxis, gram-positive bacterial protein allergies, or amide anesthetic sensitivities; and patients with bleeding disorders.

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Is RHA Redensity Eye the Same as Perioral Redensity or Redensity 1?

Brand nomenclature in aesthetic medicine often causes severe patient confusion. Revance and Teoxane market several distinct formulations under the "Redensity" and "RHA" names across global jurisdictions.

                  [The Three Redensity Formulations]

  Product SKU             US FDA Status             HA Concentration   Primary Indication
  ────────────────────    ───────────────────────   ────────────────   ──────────────────────────
  RHA Redensity Eye       FDA-Approved (May 2026)   15 mg/g            Infraorbital Hollows (22+)
  RHA Redensity (Classic) FDA-Approved (Dec 2021)   23 mg/mL           Perioral Lip Lines (22+)
  Teosyal Redensity 1     Not FDA-Approved (EU CE)  15 mg/g Non-Cross  Mesotherapy / Skin Booster

1. RHA Redensity Eye (Infraorbital SKU)

Approved under P170002/S050 on May 12, 2026, this product is formulated with a 15 mg/g concentration of sodium hyaluronate crosslinked with 1,4-butanediol diglycidyl ether (BDDE). It utilizes Teoxane's proprietary Preserved Network Technology (PNT), which preserves long, mobile HA chains with lower chemical modification (low MoD), designed to adapt to dynamic facial movement.

The FDA approved two distinct anesthetic configurations:

• RHA Redensity Eye Lido: Contains 0.3% (3 mg/g) lidocaine hydrochloride, supplied in a 1.0 mL syringe with two 30G 1/2-inch needles and an approved 36-month shelf life.
• RHA Redensity Eye: Contains 0.3% (3 mg/g) mepivacaine hydrochloride, supplied in a 1.0 mL syringe with one 30G 1/2-inch needle and one 25G 1 1/2-inch blunt-tip cannula, with a 24-month shelf life.

2. RHA Redensity (Perioral SKU)

Approved under P170002/S012 on December 22, 2021, original US RHA Redensity is a 23 mg/mL HA gel specifically indicated for injection into the mid-to-deep dermis for the correction of moderate to severe perioral rhytids (vertical lipstick lines and superficial smoker's lines). Because of its higher HA concentration, using perioral Redensity under the eyes increases hydrophilic swelling and Tyndall risk. For more on dynamic filler engineering across the full product family, see our comprehensive guide on Teoxane RHA filler technology and smoker's lines treatments.

3. Teosyal PureSense Redensity 1 (European Skin Booster)

Frequently discussed on international beauty forums, Redensity 1 is a non-crosslinked HA formulation blended with an amino acid and antioxidant dermo-restructuring complex. It is utilized in Europe and Canada as a superficial mesotherapy skin booster. Teosyal Redensity 1 is not FDA-approved in the United States. It must not be confused with the crosslinked structural gel approved under P170002/S050.

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How Does Redensity Eye Compare to Other FDA-Approved Under-Eye Fillers?

Until 2021, all infraorbital filler injections in the United States were performed off-label using standard mid-face fillers (such as Restylane-L or Juvéderm Ultra). Over the past five years, the FDA has approved four dedicated Class III PMA devices for infraorbital volume deficiency.

               [FDA-Approved Infraorbital Hyaluronic Acid Matrix]

  Filler Brand         PMA Supplement   Approval Date   HA Concentration   Crosslinking Tech
  ──────────────────   ──────────────   ─────────────   ────────────────   ──────────────────
  Juvéderm Volbella XC P110033/S053     May 28, 2021    15 mg/mL           Vycross (Short/Long)
  Restylane Eyelight   P040024/S135     May 8, 2023     20 mg/mL           NASHA (Firm Calibrated)
  Belotero Balance (+) P090016/S050     Sep 27, 2023    22.5 mg/mL         CPM (Cohesive Polydensified)
  RHA Redensity Eye    P170002/S050     May 12, 2026    15 mg/g            PNT (Dynamic Resilient)

Rheological and Clinical Differences

1. Dynamic Resilience (RHA Redensity Eye): Formulated with Teoxane's Preserved Network Technology, Redensity Eye exhibits low resistance to deformation (elastic modulus G') combined with high stretchability. This makes it particularly suited for dynamic zones around the orbicularis oculi, where excessive gel stiffness can cause visible rolling or ridging during smiling.
2. Firm Deep Structural Support (Restylane Eyelight): Built on Galderma's NASHA technology, Eyelight is a firmer, minimally crosslinked gel with high gel hardness (G') and low water uptake. It provides precise supraperiosteal projection directly on the orbital rim.
3. Low Hydrophilic Swelling (Volbella XC & Belotero): Volbella XC uses low-molecular-weight HA chains to minimize post-treatment water absorption, while Belotero's CPM technology allows seamless intradermal integration with virtually no Tyndall effect.

Those responder percents are not a ranking. Each pivotal used a different hollows scale, a different follow-up week, and a different control rate. The table is a regulatory map, not a "best filler" scoreboard.

To understand how other hyaluronic acid families behave across different anatomical planes, explore our guides on Juvéderm vs. Restylane and RHA vs. Juvéderm.

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What Did the US Clinical Trial Actually Measure?

Marketing announcements frequently blur the line between rigorous primary clinical endpoints and descriptive secondary satisfaction surveys.

                  [Pivotal Trial NCT04577898 Evidence Hierarchy]

  Primary Co-Endpoints (Blind Evaluator & PRO)     Secondary Marketing Headline
  ────────────────────────────────────────────     ────────────────────────────
  • Evaluator TIOHS ≥ 1-Grade: 79.0% vs. 9.8%      • BLE GAIS Improved: 92.8% (205/221)
  • Modified FACE-Q Score: +37.5 vs. −4.1          • Subject GAIS Improved: 84.5% (197/233)
  • Rigorous randomized, controlled comparison     • Uncontrolled pooled treated cohort

The Pivotal Study Design (NCT04577898)

The safety and effectiveness of RHA Redensity Eye were evaluated in a prospective, randomized, multi-center, no-treatment-controlled US clinical trial (NCT04577898, completed February 14, 2025) evaluating 248 enrolled subjects:

• Phase 1a (Primary Window): 183 subjects received immediate treatment with RHA Redensity Eye, while 65 control subjects received no treatment for 12 weeks before crossing over.
• Co-Primary Endpoint 1 (Blinded Live Evaluator): Proportion of subjects achieving at least a 1-grade improvement from baseline in both eyes simultaneously on the validated 5-grade Teoxane Infraorbital Hollows Scale (TIOHS) at Week 12.
• Co-Primary Endpoint 2 (Patient-Reported Outcome): Mean change from baseline at Week 12 on the modified FACE-Q Satisfaction with Lower Eyelids module.

Trial Results: Primary vs. Secondary Metrics

1. Blinded Evaluator TIOHS Success: At Week 12, 79.0% (95% CI: 72.2%–84.5%) of treated subjects met the co-primary responder definition, compared to only 9.8% (95% CI: 3.9%–22.2%) in the untreated control arm—confirming strong statistical superiority (p < 0.0001).
2. FACE-Q Patient Satisfaction: Treated subjects experienced a mean improvement of +37.5 points (SD 27.04) on the 100-point scale, compared to −4.1 points (SD 17.48) in the control group.
3. The 93% Marketing Claim Unpacked: The headline claim that "93% of patients had aesthetic improvement at 3 months" comes from SSED Table 21, which reports that 92.8% (205 of 221) of treated subjects were rated as "improved or much improved" on the Blinded Live Evaluator Global Aesthetic Improvement Scale (BLE GAIS). GAIS is a secondary global measure in a pooled treated set; it is not the TIOHS co-primary and it does not have a no-treatment contrast at that table.

Volume and Exposure Parameters

In the pivotal trial:

• Mean total volume injected across both eyes was 1.52 mL (SD 0.526).
• Per-eye volume averaged approximately 0.76 mL.
• The trial protocol set a strict maximum ceiling of 1.0 mL per eye and prohibited touch-up reinjections during the primary 12-week evaluation period.

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Safety Profile, Adverse Events, and Vascular Risk Realities

The infraorbital tear-trough zone is among the highest-risk anatomical regions in aesthetic medicine due to thin eyelid skin, delicate lymphatic drainage, and complex vascular anastomoses connecting the facial and ophthalmic arterial systems.

                    [Reported Adverse Event Rates]

  Common Treatment Responses (SSED diaries)        Key Clinical Safety Metrics
  ─────────────────────────────────────────        ───────────────────────────
  • Tenderness: 57.4% (128/223 diaries)            • Tyndall Effect (Bluish Tint): 2.8% (7/248)
  • Swelling: 57.0% (127/223)                      • Delayed-Onset Nodules: none reported in-study
  • Bruising: 54.7% (122/223)                      • In-Study Granulomas: none reported
  • Lumps/bumps: 49.3% (110/223)                   • Vascular Occlusion / Embolism: 0/248 observed*
  • Pain: 18.8% (42/223)                           *N=248 cannot bound rare periocular vascular events.

Common Injection-Site Reactions

SSED Tables 10–11 report common treatment responses from retrieved patient diaries after initial treatment (110 needle diaries and 113 cannula diaries; 223 diaries total). Combined incidence was:

• Tenderness: 57.4% (128/223)
• Swelling: 57.0% (127/223)
• Bruising: 54.7% (122/223)
• Lumps/bumps: 49.3% (110/223)
• Firmness: 44.4% (99/223)
• Pain: 18.8% (42/223)

Needle injections had more bruising (71.8%) than cannula injections (38.1%). Most diary events were mild; severe events were uncommon. Typical local reactions resolved over days to a couple of weeks.

Tyndall Effect and Lymphatic Edema

Due to the extreme thinness of infraorbital skin (often less than 0.5 mm), improperly placed hyaluronic acid can scatter light, producing a persistent bluish hue known as the Tyndall effect. In the SSED safety dataset:

• Tyndall effect was observed in 2.8% (7 of 248 subjects), all categorized as mild.
• Overfilling or superficial subcutaneous placement can also compress fragile lymphatic channels, leading to persistent lower-eyelid malar edema (water bags).

The Statistical Reality of Vascular Occlusion

The FDA SSED reported zero cases of vascular occlusion, skin necrosis, or visual impairment among the 248 trial participants.

However, prospective clinical trials of 200 to 300 patients cannot statistically bound the incidence of rare catastrophic adverse events. Accidental intra-arterial injection into the infraorbital artery, angular artery, or dorsal nasal artery can cause retrograde embolic occlusion of the central retinal artery, resulting in irreversible blindness.

To mitigate this risk, the FDA's May 12, 2026 approval order makes the product a restricted device and conditions approval on a device-specific use training program. The order requires training in facial anatomy and vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complications. The manufacturer may distribute the device only to providers who complete that program.

For detailed analysis of historical complications and safety protocols across all fillers, see dermal filler adverse events in the FDA MAUDE database.

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Skin of Color and Fitzpatrick Safety

Hyaluronic acid injections in patients with deeper skin tones (Fitzpatrick IV–VI) carry heightened risks of post-inflammatory hyperpigmentation (PIH) triggered by mechanical needle trauma or secondary bruising.

In the pivotal NCT04577898 trial:

• 33.9% of enrolled subjects (84 of 248) were classified as Fitzpatrick skin types IV, V, or VI.
• The SSED reported that adverse-device-effect rates were similar across Fitzpatrick groups and were not negatively correlated with darker phototypes.
• The trial split needle and cannula 1:1 (116 vs 117 treated subjects). That design does not prove that the 25G cannula supplied with the non-Lido SKU prevents PIH. Cannula versus needle is a technique choice, not a labeled phototype guarantee.

For an extensive analysis of cosmetic procedure safety in richly pigmented skin, see our clinical guide on treating dark circles across skin types.

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Who Should Skip Under-Eye Filler? (Hollows vs. Bags vs. Pigment)

Hyaluronic acid filler is designed solely to replace lost anatomical volume beneath the orbital rim. Attempting to treat non-volume concerns with filler is the leading cause of unnatural "pillow face" results and patient dissatisfaction.

                    [Under-Eye Differential Decision Tree]

  Primary Presentation                 Underlying Pathology        Correct Clinical Treatment
  ─────────────────────────────────    ────────────────────        ──────────────────────────
  A. True Structural Tear-Trough Gap   Sub-orbicularis fat loss    RHA Redensity Eye Filler
  B. Puffy Bulging Lower Eyelid Bags   Orbital fat herniation      Lower Blepharoplasty Surgery
  C. Dark Brown / Slate-Grey Shadow    Melanin hyperpigmentation   Topicals / Chemical Peels / Laser
  D. Thin, Translucent Skin / Veins    Vascular show-through       PRF / Ez-Gel / Skin Boosters

1. True Eye Bags (Orbital Fat Herniation)

If your under-eye concern is caused by weakening of the orbital septum allowing intraorbital fat pads to herniate forward (producing visible puffy bulges), injecting filler will make the bags look larger and heavier. These patients require surgical evaluation; see our complete guide on under-eye bags: filler vs. lower blepharoplasty and blepharoplasty costs and recovery.

2. Pigmentary Dark Circles

Dark circles caused by post-inflammatory melanin deposition or genetic hyperpigmentation cannot be cleared by clear hyaluronic acid gel. Placing clear filler under pigmented skin often accentuates the darkness by creating a pale translucent shelf underneath; see dark circles causes and treatments.

3. Biological Gel Alternatives

For patients seeking regenerative collagen stimulation without synthetic crosslinked HA, autologous platelet-rich fibrin represents an alternative path; explore our breakdown of tear-trough filler vs. PRF and Ez-Gel.

4. Labeled Contraindications

According to the FDA SSED, RHA Redensity Eye is contraindicated in patients with:

• Severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.
• Known hypersensitivity to gram-positive bacterial proteins (the gel is produced from a Streptococcus equi strain).
• Previous hypersensitivity to local anesthetics of the amide type, such as lidocaine or mepivacaine.
• Bleeding disorders.

Active infection, dermatitis, or a herpes outbreak in the field is a practical reason to delay treatment even though those are not the four labeled contraindications above. Injectors also screen anticoagulation because periocular bruising and hematoma risk rise when clotting is impaired; that is a precaution, not a fourth-plus labeled contraindication.

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Treatment Experience, Longevity, and Cost Reality

What to Expect During Treatment

1. Assessment & Marking: The injector evaluates infraorbital anatomy with the patient sitting upright, checking for orbital fat pseudoherniation, negative vector orbital support, and skin snap-back elasticity.
2. Technique & Plane: The IFU planes are the sub-dermis and supraperiosteum. In the trial, most needle cases were supraperiosteal; cannula cases were more often split across both planes. Exact aliquot size is an injector decision, not a universal dose.
3. Immediate Aftercare: Ice packs are applied gently. Patients must avoid vigorous aerobic exercise, inverted yoga positions, high-heat environments (saunas), and alcohol for 24 to 48 hours to minimize bruising and swelling.

Expected Duration

Marketing materials state that results "last up to 12 months without a touch-up." That is a manufacturer line, not a guarantee. In the SSED, 60.5% (124 of 205) of treated subjects still had at least a 1-grade TIOHS improvement at week 52, and 47.2% (110 of 233) of treated subjects received a retreatment at 52 weeks. Mean retreatment volume was lower than the initial 1.52 mL both-eyes dose. Longevity still varies with metabolism, muscle activity, and how much volume was placed.

Cost Expectations

There is no Redensity Eye national list price. Tear-trough filler is billed per syringe; this site's existing range is about $650 to $1,500 per syringe, with both-eyes totals often landing between $1,000 and $2,000. Do not treat a "new SKU" quote as a different product class. For injector-skill pricing and low-price warning signs, see tear-trough filler costs and risks.

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Frequently Asked Questions

Is RHA Redensity Eye FDA approved?

Yes. The US FDA approved RHA Redensity Eye Lido and RHA Redensity Eye under Premarket Approval (PMA) supplement P170002/S050 on May 12, 2026. Revance and Teoxane officially announced commercial availability on August 20, 2026.

Is RHA Redensity Eye the first FDA-approved under-eye filler?

No. It is the fourth hyaluronic acid filler to receive FDA approval for infraorbital hollows. Juvéderm Volbella XC was approved in May 2021, Restylane Eyelight in May 2023, and Belotero Balance (+) in September 2023.

Is this the same filler as RHA Redensity for lip lines?

No. RHA Redensity Eye is a 15 mg/g HA gel formulated specifically for delicate periocular tissue. The original RHA Redensity approved in December 2021 is a denser 23 mg/mL HA gel indicated for perioral rhytids (lipstick lines).

Can RHA Redensity Eye fix under-eye bags?

No. RHA Redensity Eye is indicated strictly for volume deficiency (hollows). True under-eye bags are caused by herniated orbital fat pads pushing forward. Injecting filler over fat bags makes the eye area look puffier and more congested. Severe bags require lower blepharoplasty surgery.

How long does RHA Redensity Eye last?

The trial protocol did not require a touch-up during the 12-week primary window. At week 52, 60.5% (124/205) of treated subjects still met a 1-grade TIOHS improvement, and just under half of treated subjects received a retreatment then. Individual duration is shorter or longer than that headline.

Is Redensity 1 available in the US?

No. Teosyal PureSense Redensity 1 is a non-crosslinked mesotherapy skin booster available in Europe and Canada. It is not FDA-approved in the United States and should not be confused with the crosslinked structural gel approved as RHA Redensity Eye.

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Sources

• FDA Premarket Approval (PMA) Database — PMA P170002/S050 (RHA Redensity Eye Lido and RHA Redensity Eye, Approved May 12, 2026): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170002S050
• FDA CDRH — Summary of Safety and Effectiveness Data (SSED) P170002/S050 (Teoxane S.A.): https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170002S050B.pdf
• FDA CDRH — PMA Approval Order P170002/S050 (12 May 2026): https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170002S050A.pdf
• ClinicalTrials.gov — A Study to Evaluate the Safety and Effectiveness of RHA Redensity Eye in Infraorbital Hollows (NCT04577898): https://clinicaltrials.gov/study/NCT04577898
• Revance Therapeutics — Revance and Teoxane Announce FDA Approval of RHA Redensity Eye for Undereye Hollowing: https://www.revance.com/news/press-releases/revance-and-teoxane-announce-the-fda-approval-of-rha-redensityr-eye-for-undereye-hollowing
• FDA Premarket Approval (PMA) Database — PMA P110033/S053 (Juvéderm Volbella XC Infraorbital Expansion, Approved May 28, 2021): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110033S053
• FDA Premarket Approval (PMA) Database — PMA P040024/S135 (Restylane Eyelight Infraorbital Hollows, Approved May 8, 2023): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040024S135
• FDA Premarket Approval (PMA) Database — PMA P090016/S050 (Belotero Balance (+) Infraorbital Expansion, Approved September 27, 2023): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P090016S050
• American Society of Plastic Surgeons (ASPS) — Dermal Fillers Procedure Guide & Safety: https://www.plasticsurgery.org/cosmetic-procedures/dermal-fillers
• ClinicalTrials.gov — Juvéderm Volbella XC for Infraorbital Hollows (NCT03418545): https://clinicaltrials.gov/study/NCT03418545
• ClinicalTrials.gov — Restylane Eyelight for Infraorbital Hollows (NCT04154930): https://clinicaltrials.gov/study/NCT04154930