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Revance and Teoxane Announce the FDA Approval of RHA Redensity® Eye for Undereye Hollowing

RHA Redensity Eye delivers natural-looking results that last up to 12 months in the infraorbital hollows.¹

Nashville, TN – August 20, 2026 – Revance and Teoxane announce the FDA approval of RHA Redensity Eye from the Teoxane RHA® Collection for the correction of moderate to severe tissue volume deficiencies in the undereye region, also referred to as “infraorbital hollows”, in adults aged 22 years or older.1 The infraorbital region is anatomically complex and one of the most expressive areas of the face, making proper filler selection critical to achieving natural-looking results.2-3  The rheological profile of RHA Redensity Eye is uniquely optimized to deliver the highest dynamic strength and stretch of any hyaluronic acid (HA) filler for undereye treatment on the market.4-5

Powered by the Teoxane RHA Collection’s proprietary Preserved Network Technology (PNT), a gentle, heatless, homogenous manufacturing process that helps preserve the natural structure of HA, RHA Redensity Eye is designed to adapt to the delicate dynamics of the undereye area with results lasting up to 12 months.1,4,6-9 Additionally, the undereye region is an area of critical aesthetic consideration for patients on GLP-1 therapies as it is a common area for exhibiting fat loss.10

“The FDA approval of RHA Redensity Eye for the infraorbital region is the latest advancement in what has been a defining period for the Teoxane RHA Collection. Following the launch of the Teoxane RHA Collection with mepivacaine in August 2025 and RHA Dynamic Volume March 2026, we are continuing to expand our portfolio into the areas patients care about most, and the infraorbital region is one of the most delicate and sought-after in facial rejuvenation,” said Nadeem Moiz, CEO of Revance. “We remain committed to delivering innovative, clinically proven solutions that give both patients and practitioners the confidence to achieve natural-looking results.”

This approval is supported by positive results from the 52-week U.S. pivotal clinical study, where the safety and effectiveness of RHA Redensity Eye were evaluated in a prospective, randomized, evaluator-blinded, multicenter, no-treatment controlled study in patients with moderate to severe tissue volume deficiencies in the infraorbital region.1,11 In that study, 93% of patients showed aesthetic improvement at 3 months.11 Additionally, the study achieved results lasting up to 12 months without any touch-ups.1,12-14

“Treating the periorbital area is not straightforward,” said Madame Valérie Taupin, CEO and Founder of Teoxane. “The properties of RHA Redensity Eye provides an answer for it. Its spreadability, stretch, and soft profile are exactly what this anatomy requires. This U.S. approval is a meaningful milestone, not just commercially, but as a confirmation that our technology and precision formulation matters.”

RHA Redensity Eye is also the first hyaluronic acid gel to demonstrate effectiveness using patient-reported outcomes as a co-primary endpoint in a U.S. clinical study for the infraorbital region.1 RHA Redensity Eye exhibited a favorable safety profile with no late-onset or serious treatment-related adverse events (TRAEs), no TRAEs deemed to be a granuloma or delayed inflammatory response, and no events of vascular occlusion.1

“The FDA approval of RHA Redensity Eye for the infraorbital region marks a meaningful step forward for patients and practitioners alike,” said board certified dermatologist and principal investigator on the RHA Redensity Eye clinical trial, Dr. Joely Kaufman-Janette. “As a practitioner, there has long been a need for a filler that meets the unique demands of the undereye area. I'm looking forward to offering my patients a meaningful new option for one of the most requested areas of the face.”

Learn more about the Teoxane RHA Collection at rha.revanceaesthetics.com.



About Revance:
Revance is a global company developing, producing, and distributing industry-leading, differentiated products across aesthetics, skincare, and therapeutics. Revance drives innovation beyond convention to offer treatment options for individuals across generations. The Company's vision is to redefine excellence in aesthetics, skincare, and therapeutics through science-powered innovation, with an unwavering commitment to its providers, patients, and consumers. Revance's award-winning products are the result of robust research and development, a cornerstone for the Company, driven by renowned scientists. For more information about Revance, please visit us at www.revance.com.

About Teoxane:
Founded by Valérie Taupin in 2003, Teoxane specializes in developing solutions using hyaluronic acid. With over 20 years of expertise, it is a pioneer in the science of facial beauty. The company was founded on a unique vision: to open the possibilities of aesthetic treatments using high-performance dermal and dermo-cosmetic fillers developed through in-depth scientific research. Through attentive listening, education and establishing the foundations for a safer industry, Teoxane has ushered in a new era in aesthetic medicine. Here, minor beauty procedures wield a significant impact on a patient's self-image and overall well-being. www.teoxane.com



Media Contact: 
EvolveMKD
Revance@EvolveMKD.com



RHA® Collection of Fillers, by Teoxane 
The Teoxane RHA® Collection includes hyaluronic acid (HA) fillers with lidocaine and mepivacaine. Revance will only distribute the Teoxane RHA® Collection with Mepivacaine, and thus may refer to the products without the use of "Mepi" in the product name. The long-term efficacy and safety outcomes of RHA® with lidocaine are
applicable to RHA® with mepivacaine, and mepivacaine has shown no significant impact on gel properties, including rheology and degradation profile.

RHA® Collection of Fillers, by Teoxane Approved Uses
The Teoxane RHA® Collection of resilient hyaluronic acid (HA) fillers includes RHA Redensity®, RHA®2, RHA® 3 and RHA® 4 with lidocaine and RHA Redensity® Mepi, RHA Redensity® Eye, RHA® 2 Mepi, RHA® 3 Mepi and RHA® Dynamic Volume, with mepivacaine.

RHA Redensity® and RHA Redensity® Mepi are for injection into the facial tissue for the correction of moderate to severe dynamic perioral rhytids. RHA Redensity® Eye is for the correction of moderate to severe tissue volume deficiencies in the infraorbital region, in adults aged 22 years or older. RHA® 2, RHA® 2 Mepi and RHA® 4 are for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLFs), in adults 22 or older. RHA® 3 and RHA® 3 Mepi are for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLFs), and also used to augment lip fullness in adults 22 or older. RHA® Dynamic Volume is for correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLFs) and for cheek augmentation and/or correction of age-related midface contour deficiencies in adults 22 or older.


IMPORTANT SAFETY INFORMATION

Are there any reasons why I should not receive any RHA® injectable gel formulation? Do not receive if you have a history of multiple severe allergies or severe allergic reactions; if you are allergic to lidocaine or mepivacaine or gram-positive bacterial proteins; or if you have a bleeding disorder.

What precautions should I discuss with my doctor?

·      Tell your doctor if you are pregnant or breastfeeding as the safety of these products for use during pregnancy or while breastfeeding has not been studied
·      Tell your doctor if you have a history of excessive scarring, keloid formations or pigmentation disorders, as use of these products may result in additional scars or changes in pigmentation
·      Tell your doctor if you are planning laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment
·      Tell your doctor if you are on immunosuppressive therapy used to decrease your immune response, as use of these products may result in an increased risk of infection
·      Tell your doctor if you are using medications that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may increase bruising or bleeding at the injection site
·      The safety and effectiveness of RHA¬Æ fillers in areas other than those indicated have not been established in U.S. clinical studies
·      Patients who experience skin injury near the site of injection with this product may be at a higher risk for side effects
·      Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment

What are possible side effects?

The most commonly reported side effects included injection-site redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching.

One of the risks with using these products is unintentional injection into a blood vessel, and while rare, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring.

Delayed-onset inflammation and granulomas, red raised lumps, near the site of dermal filler injections are known side effects associated with dermal fillers. Cases of delayed-onset inflammation have been reported to occur at the treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to being treated or resolved on its own. Granulomas may appear weeks or months after injection and may require medical intervention.

Typically, the reported inflammation was responsive to being treated or resolved on its own.

As with all skin injection procedures, there is a risk of infection and recurrence of herpetic eruptions.

To report an adverse event with any RHA® product to Revance, please visit Safety.Revance.com or call at 1 (877) 373-8669.

Please visit RHACollection.com or talk to your doctor for more information.

RHA® and RHA Redensity® are registered trademarks of TEOXANE SA, manufactured in Switzerland. The Teoxane RHA® Collection is exclusively distributed by Revance®. All other trademarks are the property of their respective owners.

Available by prescription only. RHA-00220

References:
1. RHA Redensity® Eye Instructions for Use (IFU), P170002S050D.
2. Bhojani-Lynch et al. Aesthet Surg J Open Forum. 2025:7:ojaf069.
3. Hwang CJ. J Cutan Aesthet Surg. 2016;9(2):73–79.
4. Faivre et al. Dermatol Surg. 2021;47(5):e159–e167.
5. Data on File. RDRE 2016. Geneva, Switzerland, Teoxane S.A.
6. Data on File. TEO-® -2004. Geneva, Switzerland, Teoxane S.A., 2025.
7. Monheit et al. Dermatol Surg. 2020;46(12):1521-1529.
8. Kaufman-Janette et al. J Cosmet Dermatol. 2019;18(5):1244-1253.
9. Vantou et al. Unraveling the Key Characteristics of the Preserved Network Technology (PNT): Manufacturing the Dynamic RHA® Fillers.
10. Jafar et al. Aesthet Surg J Open Forum. 2024; 22:6:ojae069.
11. Clinical Study TEO-RHA-1902.Geneva, Switzerland, Teoxane S.A., 2025.
12. Fabi et al. Aesthet Surg J. 2021;41(11):NP1675–NP1685.
13. Biesman et al. Aesthet Surg J. 2024;44(9):1001-1013.
14. Biesman et al. Aesthet Surg J. 2024;44(9):976–986.

###


IMPORTANT SAFETY INFORMATION for DAXXIFY® (daxibotulinumtoxinA-Ianm) injection, Teoxane RHA® Collection, and SkinPen®

WARNING: DISTANT SPREAD OF TOXIN EFFECT
The effects of DAXXIFY® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. DAXXIFY® is not approved for the treatment of spasticity or any conditions other than cervical dystonia and glabellar lines...

DAXXIFY® (daxibotulinumtoxinA-lanm) injection IMPORTANT SAFETY INFORMATION

INDICATION

DAXXIFY® (daxibotulinumtoxinA-lanm) injection is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients and for the treatment of cervical dystonia in adults.

WARNING: DISTANT SPREAD OF TOXIN EFFECT
The effects of DAXXIFY® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. DAXXIFY® is not approved for the treatment of spasticity or any conditions other than cervical dystonia and glabellar lines.

IMPORTANT SAFETY INFORMATION


Contraindications

DAXXIFY® contraindications include hypersensitivity to any botulinum toxin preparation or any of the components in the formulation and infection at the injection site(s).

Warnings and Precautions

Please refer to Boxed Warning for Distant Spread of Toxin Effect.

The potency units of DAXXIFY® are not interchangeable with preparations of other botulinum toxin products. Recommended dose and frequency of administration should not be exceeded. Patients should seek immediate medical attention if respiratory, speech or swallowing difficulties occur. Use caution when administering to patients with pre-existing cardiovascular disease. Concomitant neuromuscular disorders may exacerbate clinical effects of treatment.

Adverse Reactions

The most commonly observed adverse reactions are:
Glabellar lines (≥1%): headache (6%), eyelid ptosis (2%) and facial paresis (1%).
Cervical dystonia (≥5%): headache (9%), injection site pain (8%), injection site erythema (5%), muscular weakness (5%), and upper respiratory tract infection (5%).

Drug Interactions

Co-administration of DAXXIFY® and aminoglycoside antibiotics, anticholinergic agents or any other agents interfering with neuromuscular transmission or muscle relaxants should only be performed with caution as the effect of DAXXIFY® may be potentiated. The effect of administering different botulinum neurotoxins during course of treatment with DAXXIFY® is unknown.

Use in Specific Populations

DAXXIFY® is not recommended for use in children or pregnant women.

Please see DAXXIFY® full Prescribing Information, including Boxed Warning and Medication Guide.

To report side effects associated with DAXXIFY®, please visit safety.revance.com, or call 1-877-373-8669. You may also report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch

[DAXI-004726]

The long-term efficacy and safety outcomes of RHA® with lidocaine are applicable to RHA® with mepivacaine and mepivacaine has shown no significant impact on gel properties, including rheology and degradation profile.

PLEASE SEE FULL DIRECTIONS FOR USE

RHA® Collection of Fillers, by Teoxane

Indications


The Teoxane RHA® Collection of resilient hyaluronic acid (HA) fillers includes RHA Redensity®, RHA® 2, RHA® 3 and RHA® 4 with lidocaine and RHA Redensity® Mepi, RHA® 2 Mepi, RHA® 3 Mepi and RHA® Dynamic Volume, with mepivacaine.

RHA Redensity® and RHA Redensity® Mepi are indicated for injection into the dermis and superficial dermis of the face, for the correction of moderate to severe dynamic perioral rhytids in adults 22 or older. RHA® 2 and RHA® 2 Mepi are indicated for injection into the mid-to-deep dermis for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLFs) in adults 22 or older. RHA® 3 and RHA® 3 Mepi are indicated for injection into the mid-to-deep dermis for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLFs) and is also indicated for injection into the vermillion body, vermillion border and oral commissure to achieve lip augmentation and lip fullness in adults 22 or older. RHA® 4 is indicated for injection in the deep dermis to superficial subcutaneous tissue for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLFs) in adults 22 or older. RHA® 4 is indicated for injection in the deep dermis to superficial subcutaneous tissue for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLFs) and for injection into the subcutaneous to supraperiosteal layers for cheek augmentation and/or correction of age-related midface contour deficiencies in adults 22 or older.

IMPORTANT SAFETY INFORMATION


Contraindications


Do not use in patients who have severe allergies, marked by a history of anaphylaxis or multiple severe allergies, or in patients with a history of allergies to gram-positive bacterial proteins or local anesthetics of the amide type, such as lidocaine and mepivacaine.

Do not use in patients with bleeding disorders.

Warnings


Do not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, inject the product slowly and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures.

Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur.

Product use at specific sites in which an active inflammatory process or infection is present should be deferred until the underlying process has been controlled.

Precautions


These products should only be used by healthcare professionals who have appropriate training, experience, and knowledge of facial anatomy.

Discuss the potential risks of soft-tissue injections with your patients prior to treatment and ensure that patients are aware of signs and symptoms of potential complications.

The safety and effectiveness for the treatment of anatomic regions other than the labeled indications have not been established in controlled U.S. clinical studies

As with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed.

The safety for use in sites in the presence of other implants, during pregnancy, in breastfeeding females, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied.

Use with caution in patients on immunosuppressive therapy.

Patients who are using products that can prolong bleeding (such as thrombolytics, anticoagulants, or inhibitors of platelet aggregation) may experience increased bruising or bleeding at treatment sites.

Patients with a history of herpetic eruptions may experience reactivation of the herpes.

There is a possible risk of inflammation at the implant site if laser treatments or a chemical peel are performed after treatment.

Use as supplied. Modification or use of the product outside the Directions for Use may adversely impact the sterility, safety, homogeneity, or performance of the product.

For single patient use. Do not reuse a syringe between two treatments and/or between two patients. Do not resterilize.

Adverse Events


The most commonly reported side effects were firmness, redness, tenderness, swelling, lumps/bumps, bruising, discoloration, pain and itching. Most of these events were mild or moderate and resolved within 14 days.

Delayed-onset inflammation near the site of dermal filler injections is one of the known adverse events associated with dermal fillers. Cases of delayed-onset inflammation have been reported to occur at the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to treatment or resolved on its own.

To report an adverse event with any RHA® product to Revance, please visit Safety.Revance.com or call at 1 (877) 373-8669.

RHA® and RHA Redensity® are registered trademarks of TEOXANE SA, manufactured in Switzerland. The Teoxane RHA® Collection is exclusively distributed by Revance®. All other trademarks are the property of their respective owners.

Available by Prescription only

RHA-00221

The SkinPen system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II – IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older. Rx only. To view SkinPen intended use, important safety information, and clinical trial details (data on file), contact us at regenerativemarketing@revance.com.

SkinPen®

Indications for Use

The SkinPen® Precision Elite, SkinPen® Precision and MicroPen EVO™ systems are microneedling devices and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older. Indications and body treatment areas may vary based on your country.

Contraindications

The use of the SkinPen® Precision Elite, SkinPen® Precision and MicroPen EVO™ systems should not be used on patients who have active skin cancer in the treatment area(s), have open wounds, sores, or irritated skin in the treatment area(s), have an allergy to stainless steel or anesthetics, have a hemorrhagic (bleeding) disorder or hemostatic (bleeding) dysfunction, are pregnant or nursing, are currently taking drugs with the ingredient isotretinoin (such as Accutane®). Note: These products are not intended for transdermal (under the skin) delivery of topical products such as cosmetics, drugs, or biologics. For full safety information, instructions for use manual and clinical trial details, as applicable, visit us at skinpen.com and micropenevo.com.

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©2026 REVANCE. RHA® and RHA Redensity® are registered trademarks of TEOXANE SA, manufactured in Switzerland. The Teoxane RHA® Collection is exclusively distributed by REVANCE. All other trademarks are the property of their respective owners. CORP-00147

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