Revance与Teoxane宣布RHA Redensity Eye获FDA批准用于泪沟填充

RHA Redensity Eye delivers natural-looking results that last up to 12 months in the infraorbital hollows.1
NASHVILLE, Tenn., Aug. 20, 2026 /PRNewswire/ -- 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
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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® 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:
- RHA Redensity® Eye Instructions for Use (IFU), P170002S050D.
- Bhojani-Lynch et al. Aesthet Surg J Open Forum. 2025:7:ojaf069.
- Hwang CJ. J Cutan Aesthet Surg. 2016;9(2):73–79.
- Faivre et al. Dermatol Surg. 2021;47(5):e159–e167.
- Data on File. RDRE 2016. Geneva, Switzerland, Teoxane S.A.
- Data on File. TEO-® -2004. Geneva, Switzerland, Teoxane S.A., 2025.
- Monheit et al. Dermatol Surg. 2020;46(12):1521-1529.
- Kaufman-Janette et al. J Cosmet Dermatol. 2019;18(5):1244-1253.
- Vantou et al. Unraveling the Key Characteristics of the Preserved Network Technology (PNT): Manufacturing the Dynamic RHA® Fillers.
- Jafar et al. Aesthet Surg J Open Forum. 2024; 22:6:ojae069.
- Clinical Study TEO-RHA-1902.Geneva, Switzerland, Teoxane S.A., 2025.
- Fabi et al. Aesthet Surg J. 2021;41(11):NP1675–NP1685.
- Biesman et al. Aesthet Surg J. 2024;44(9):1001-1013.
- Biesman et al. Aesthet Surg J. 2024;44(9):976–986.
SOURCE Revance