TABLE 1.
Approved hydrogel products grouped by broad indications and materials.
| Name (company) | Hydrogel material/payload | Administration method | Approved indication | Approval year | |
|---|---|---|---|---|---|
| Injectable hydrogel products | |||||
| Facial correction: synthetic | Radiesse®(+) (Merz Pharmaceutical) a | Hydroxylapatite, carboxymethylcellulose with lidocaine | Dermis | Correction of wrinkles and folds, stimulation of natural collagen production | FDA (2015) |
| Radiesse® (Bioform Medical, Inc.) a | Hydroxylapatite, carboxymethylcellulose | Dermis | Correction of facial folds and wrinkles, signs of facial fat loss and volume loss | EMA (2004), FDA (2006 for first indication) | |
| Artefill® (Suneva Medical, Inc.) a | Polymethylmethacrylate beads, collagen, and lidocaine | Dermis | Facial wrinkles and folds | FDA (2006) | |
| Bellafill® PMMA Collagen Dermal Filler (Suneva Medical, Inc.) | Polymethylmethacrylate beads, Bovine collagen, and lidocaine | Dermis | Wrinkles and acne scars | FDA (2006 for first indication) | |
| Ellansé (Sinclair) | Polycaprolactone (PCL) microspheres in carboxymethyl cellulose hydrogel | Dermis | Correction of wrinkles and folds, stimulation of natural collagen production | CE (2009) | |
| Facial correction: natural | Belotero balance®(+) Lidocaine (Merz Pharmaceuticals) a | Hyaluronic acid with lidocaine | Dermis | Moderate to severe facial wrinkles and folds | FDA (2019) |
| Revanesse® Versa, Revanesse® Ultra (Prollenium Medical Technologies, Inc.) a | Hyaluronic acid | Dermis | Moderate to severe facial wrinkles and folds | FDA (2017) | |
| Revanesse® Versa+ (Prollenium Medical Technologies, Inc.) a | Hyaluronic acid with lidocaine | Dermis | Moderate to severe facial wrinkles and folds | FDA (2018) | |
| Revanesse® Lips+ (Prollenium Medical Technologies, Inc.) | Hyaluronic acid | Lips | Restore lost volume and create a fuller‐looking lip | FDA (2020) | |
| Teosyal® RHA (Teoxane SA) a | Hyaluronic acid | Dermis | Facial wrinkles and folds | EMA (2015), FDA (2017) | |
|
Restylane® Lyft, Restylane® Refyne, Restylane® Defyne (Galderma Laboratories, L.P.) a Restylane® Silk (Valeant Pharmaceuticals North AmericaLLC/Medicis) a Restylane® Injectable Gel (Medicis Aesthetics Holdings, Inc.) a Restylane® Kysse, Restylane® Eyelight (Galderma Laboratories, L.P.) |
Hyaluronic acid with lidocaine | Subcutaneous, dermis, lips | For correction of volume deficit, facial folds and wrinkles, midface contour deficiencies, perioral rhytids, and infraorbital hollowing | EMA (2010), FDA (2012 for first indication, 2023 for last indication) | |
| Belotero balance® (Merz Pharmaceuticals) a | Hyaluronic acid | Dermis | Moderate to severe facial wrinkles and folds | EMA (2004), FDA (2011 for first indication) | |
| Juvéderm® XC (Allergan, Inc.) a | Hyaluronic acid with lidocaine | Facial tissue | Correction of facial wrinkles and folds | FDA (2010) | |
| Evolence® Collagen Filler (Colbar Lifescience) a | Collagen | Dermis | Moderate to deep facial wrinkles and folds | EMA (2004), FDA (2008) | |
| Elevess® (Anika Therapeutics) a | Hyaluronic acid with lidocaine | Dermis | Moderate to severe facial wrinkles and folds | FDA (2006), EMA (2007) | |
| Juvéderm® Voluma XC/Ultra XC/Volbella XC/Vollure XC/VOLBELLA XC/VOLUX XC (Allergan, Inc.) a | Hyaluronic acid | Facial tissue, cheek, lips | For correction of facial wrinkles and folds, volume loss, lip augmentation, undereye hollows, and jawline definition | EMA (2000), FDA (2006 for first indication, 2022 for last indication) | |
| Hylaform® (Hylan B gel), Captique Injectable Gel, Prevelle Silk (Genzyme Biosurgery) a | Modified hyaluronic acid derived from a bird (avian) source | Dermis | Correction of moderate to severe facial wrinkles and folds | EMA (1995), FDA (2004) | |
| Collagen Implant, CosmoDerm® 1 human‐based collagen, CosmoDerm® 2 human‐based collagen CosmoPlast® human‐based collagen (Inamed Corporation/Allergan, Inc.) a | Human collagen | Superficial papillary dermis | For correction of soft tissue contour deficiencies, such as wrinkles and acne scars | FDA and EMA (2003) | |
| Fibrel® (Serono Laboratories) a | Collagen | Dermis | For correction of depressed cutaneous scars | FDA (1988) | |
| Zyplast(R)® and Zyderm(R)® (Inamed Corporation/Allergan, Inc.) a | Bovine collagen | Dermis | For correction of contour deficiencies | FDA and EMA (1981) | |
| RHA® 2, 3, 4, Redensity (Teoxane S.A.) | Hyaluronic acid, 1,4‐butanediol diglycidyl ether with lidocaine | Dermis | Correction of moderate to severe dynamic perioral rhytids | FDA (2017 for first indication, 2021 for last indication) | |
| SKINVIVE by JUVÉDERM (Allergan) | Hyaluronic acid, 1,4‐butanediol diglycidyl ether with lidocaine | Intradermal | Improve the smoothness of the cheeks | FDA (2023) | |
| Tissue fusion, repair and regeneration: synthetic | Emdogain (Straumann) | Porcine enamel matrix derivative in propylene glycol alginate gel | Flap incision or flapless injection | Regenerates periodontal tissue (cementum, periodontal ligament, bone) | FDA (1996) |
| PerioGlas (NovaBone) | Calcium phosphosilicate particles, a PEG and glycerine gel‐like binder | Injection | Dental bone regeneration | FDA (2005) | |
| Actifuse (Baxter) | Phase‐pure silicon‐substituted calcium phosphate in poloxamer 407 | Injection | Bone void filler in spinal and orthopedic application | FDA (2018) | |
| Dynagraft II (IsoTis Orthobiologics) | Demineralized bone matrix in poloxamer | Injection | Bone void filler | FDA (2005) | |
| AlloFuse Plus Paste, AlloFuse Plus Putty (AlloSource) | Allographic demineralized bone matrix in polyethylene oxide polypropylene oxide block copolymer | Spinal fusion or injection to trauma area | Void filler, graft extender | FDA (2011) | |
| Optium DBM Gel (LifeNet Health) | Allographic demineralized bone matrix in glycerol | Spinal fusion or injection to trauma area | Bone graft extender and void filler | FDA (2005) | |
| Grafton DBM gel (Medtronic) | Allographic demineralized bone matrix in glycerol | Spinal fusion or injection to trauma area | Bone graft extender and void filler | FDA (2005) | |
| Arthrosamid (Contura International) | Polyacrylamide | Intraarticular | Treatment of pain in osteoarthritis (OA) | CE(2007), FDA (2014) | |
| GelrinC® (Regentis Biomat.) | PEG diacrylate with denatured fibrinogen | Intraarticular injection after microfracture | Treatment of focal cartilage lesions | CE (2017) | |
| Tissue fusion, repair and regeneration: natural | INFUSE® bone graft (Medtronic Sofamor Danek USA, Inc.) a | Collagen and recombinant human bone morphogenetic protein‐2 | Spinal injection | Spinal fusion, and spine, oral‐maxillofacial and orthopedic trauma surgeries | FDA (2002 for first indication) |
| Osteogenic protein 1 (OP‐1®) implant, OP‐1® Putty (Stryker Biotech) a | Collagen, carboxymethylcellulose, and recombinant OP‐1 | Spinal injection | Posterolateral lumbar spinal fusion | FDA (2001) | |
| Algisyl‐LVR® Hydrogel Implant (LoneStar Heart, Inc.) a | Alginate | Percutaneous | Advanced heart failure | EMA (2014) | |
| Tactoset (Anika Therapeutics) | Hyaluronic acid with calcium phosphate | Injection | Bone void filler for orthopedic application, augmentation of hardware and support of bone fragments during surgery | FDA (2019 for first indication) | |
| Kinex Bioactive Gel (Globus Medical) | Bioglass, collagen and hyaluronic acid | Injection | Bone void filler | FDA (2013) | |
| EUFLEXXA® (Ferring Pharmaceuticals, Inc.) a | Hyaluronic acid | Intra‐articular | Treatment of pain in osteoarthritis (OA) | FDA (2004), EMA (2005) | |
| Gel‐One (Zimmer Biomet) | Cinnamic acid functionalized hyaluronic acid | Intraarticular injection | Treatment of pain in osteoarthritis (OA) | FDA (2011) | |
| Monovisc (Anika Therapeutics) | High MW hyaluronic acid lightly crosslinked with biscarbodiimide | Intraarticular injection | Treatment of pain in osteoarthritis (OA) | CE (2007), FDA (2014) | |
| Cingal (Anika Therapeutics) | High MW hyaluronic acid lightly crosslinked with biscarbodiimide and triamcinolone hexacetonide | Intraarticular injection | Treatment of pain in osteoarthritis (OA) | CE (2016) | |
| Hymovis (Fidia Farmaceutici) | Hyaluronic acid 500–730 kDa, functionalized with 2%–3% hexadecylamine | Intraarticular injection | Treatment of pain in osteoarthritis (OA) | FDA (2015) | |
| TRIVISC (Orthogenrx, Inc.) | Hyaluronic acid | Intraarticular injection | Treatment of pain in osteoarthritis (OA) | FDA (2017) | |
| SINOVIAL (IBSA INSTITUT BIOCHIMIQUE SA) | Hyaluronic acid | Intraarticular injection | Treatment of pain in osteoarthritis (OA) | FDA (2014) | |
| SYNOJOYNT (Arthrex, Inc.) | Hyaluronic acid | Intraarticular injection | Treatment of pain in osteoarthritis (OA) | FDA (2018) | |
| Orthovisc (Anika Therapeutics) | Hyaluronic acid | Intraarticular | Treatment of pain in osteoarthritis (OA) | FDA (2004) | |
| BST‐CarGel® (Smith & Nephew) | Chitosan | Mini‐arthrotomy or arthroscopy | Cartilage repair | CE (2012) | |
| Drug delivery device: synthetic | Jelmyto (UroGen Pharma) | Pluronic F‐127, PEG‐400, HPMC/mitomycin | Catheter instillation | Low‐grade upper tract urothelial cancer | FDA (2020) |
| Vantas® (Endo Pharmaceuticals) a | Histrelin acetate, poly(2‐hydroxyethyl methacrylate), poly(2‐hydroxypropylmethacrylate) and gonadotropin releasing hormone | Subcutaneous | Palliative treatment of prostate cancer | FDA (2004), EMA (2005) | |
| Others | TraceIT® Hydrogel Tissue Marker (Augmenix, Inc.) a | Polyethylene glycol | Percutaneous | Improved soft tissue alignment for image‐guided therapy | FDA (2013) |
| Supprelin LA® (Indevus Pharmaceuticals, Inc.) a | Histrelin acetate, poly(2‐hydroxyethyl methacrylate) | Subcutaneous | Central precocious puberty | EMA (2005), FDA (2007) | |
| Bulkamid® hydrogel (Searchlight Pharma) a | Polyacrylamide | Transurethral | Female stress urinary incontinence | EMA (2003), FDA (2006) | |
| Coaptite® (BioForm Medical, Inc.) a | Calcium hydroxylapatite, sodium carboxymethylcellulose, glycerin | Submucosal | Female stress urinary incontinence | EMA (2001), FDA (2005) | |
| SpaceOAR® Hydrogel (Augmenix, Inc.) a | Polyethylene glycol | Percutaneous | For protecting vulnerable tissues during prostate cancer radiotherapy | EMA (2010), FDA (2015) | |
| Solesta® (Oceana Therapeutics, Inc.) | Hyaluronic Acid (NASHA) and dextranomer (Dx) | Injection | Fecal incontinence | FDA (2011) | |
| Non‐injectable hydrogel products | |||||
| Drug delivery device: synthetic | Cervidil (Ferring Laboratories) | PEG 8000, dicyclohexyl methane‐4, 4′‐diisocyanate and 1,2,6‐hexanetriol/dinoprostone | Vaginal insert | Initiation and/or continuation of cervical ripening in pregnant women at or near term | FDA (1993) |
| Zuplenz TM (Galena Bipharma) | PEG 1000, polyvinyl alcohol and rice starch/Ondansetron | Oral gel | Chemotherapy, radiation, and postoperative‐induced nausea and vomiting | FDA (1991) | |
| Tissue repair: natural | Apligraf (Organogenesis) | Collagen with fibroblast and keratinocytes | Petroleum jelly–impregnated gauze | Diabetic foot ulcer and venous leg ulcers | FDA (2000) |
| GRAFTJACKET Now (Wright Medical Group) | Collagen with different cells | Surgical implant | Tendon and ligamentous tissue repair | FDA (2010) | |
| OrthADAPT (Synovis Orthopedic and Woundcare) | Collagen with different cells | Implant | Attaching tissue to bone, tendon repair | FDA (2005) | |
| Permaco (Covidien) | Collagen | Implant | Tendon and ligamentous repair, surgical implant for ventral hernia repair and abdominal wall reconstruction | FDA (2005) | |
| TissueMend (Stryker) | Collagen | Implant | Tendon and ligamentous repair | FDA (2006) | |
| Zimmer Collagen Repair Patch (Tissue Science Laboratories) | Collagen | Implant | Rotator cuff and tendon repair | FDA (2006) | |
| OrthADAPT® Bioimplant (Pegasus Biologics) | Collagen | Surgical mesh | Attachment of tissue to bone, tendon repair | FDA (2012) | |
| TissueMend® (TEI Biosciences) | Collagen | Implant | Tendon and ligament repair | FDA (2002) | |
| Zimmer® Collagen Repair Patch (Zimmer Biomet) | Collagen | Implant | Rotator cuff and tendon repair | FDA (2002) | |
| Permacol® (Medtronic) | Porcine decellularized matrix | Implant | Tendon and ligament repair, surgical implant for ventral hernia repair and abdominal wall reconstruction | FDA (1999) | |
| Tissue repair: synthetic | DuraSeal (Duraseal) | PEG ester, trilysine amine, decahydrated sodium borate, and others | Surgical implant | Prevention of cerebrospinal fluid leakage after cranial and spinal surgery | FDA (2005) |
| Contact lenses and other ocular applications: synthetic | Airsoft™ (Maxvue Vision) | Silicone | Contact lens | Astigmatism | CE (2009) |
| Abiliti Overnigh Therapeutic Lenses, ACUVUE OASYS (Johnson & Johnson) | Silicone | Contact lens | Myopia and/or hyperopia | FDA (2021); FDA (2018) | |
| Clariti 1 day (Cooper Vision) | Silicone | Contact lens | Short sight and long sight | FDA (2018) | |
| MiSight 1 Day (BenQ) | Omafilcon A | Contact lens | Myopia | FDA (2019) | |
| Dailies AquaComfort (Ciba Vision) | Nelfilcon A | Contact lens |
Astigmatism; optical correction of refractive ametropia |
FDA (2018) | |
| Proclear (Omafilcon B) (Cooper Vision) | 2‐Hydroxyethylmethacrylate and 2‐methacryloxyethyl phosphorylcholine, ethylene glycol dimethacrylate | Contact lens | Daily wear for correction of visual acuity | FDA (2013) | |
| Resure Sealant (Ocular Therapeutix) | PEG | Topical | Intraoperative management of clear corneal incisions following cataract surgery | FDA (2014) | |
| Restasis (Allergan) | Carbomer copolymer type A with cyclosporine | Topical/eye drop | Increase tear production | FDA (2002) | |
| Yutiq (EyePoint Pharmaceuticals) | Polyvinyl alcohol with fluocinolone acetonide | Intravitreal implant | Chronic non‐infectious uveitis affecting the posterior segment of the eye | FDA (2018) | |
| Ozurdex (Allergen) | PLGA with dexamethasone | Intravitreal implant | Macular edema, non‐infectious uveitis | FDA (2009) | |
| Iluvien (Alimera Sciences) | Polyvinyl alcohol, silicone adhesives with fluocinolone acetonide | Intravitreal implant | Diabetic macular edema | FDA (2014) | |
| Azasite (Merck) | Poloxamer407, polycarbophil with azithromycin | Topical/eyedrop | Bacterial conjunctivitis | FDA (2007) | |
| BromSite (Sun Pharmaceutical Industries, Inc.) | Poloxamer407, polycarbophil with bromfenac sodium sesquihydrate | Topical/Ocular instillation | Postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery | FDA (2016) | |
| Besivance (Bausch + Lomb) | Poloxamer407, polycarbophil with besifloxacin | Topical/Ocular instillation | Bacterial conjunctivitis | FDA (2009) | |
| Bausch + Lomb ULTRA (Bausch + Lomb) | Samfilcon A | Contact lens | Near‐sightedness, far‐sightedness, and astigmatism | FDA (2018) | |
| SBL‐3 Multifocal Intraocular Lens (Lenstec, Inc.) | Hydrophilic acrylic | Intraocular | Vision correction after the eye's natural lens is removed because of cataract | FDA (2022) | |
| Precision7; Precision7 for Astigmatism; Precision7 Multifocal; Precision7 Multifocal Toric (Alcon) | Senofilcon A | Contact lens | Myopia, hyperopia, astigmatism | FDA (2023) | |
| Timoptic XE (Bausch + Lomb) | Anionic heteropolysaccharide with timolol maleate | Topical/eyedrop | Elevated intraocular pressure in patients with ocular hypertension or open‐angle glaucoma | FDA (1993) | |
| EVO ICL and EVO TICL (STAAR Surgical Company) | Collamer | Intraocular | Astigmatism and nearsighted | FDA (2022) | |
| Visian® Toric ICL (STAAR Surgical Company) | Collamer | Intraocular | Myopia and astigmatism | FDA (2018) | |
| Wound dressing: synthetic | 3 M™ Tegaderm™ hydrogel wound filler (3 M) | Propylene glycol | Dermal wound filler | Low to moderate draining wounds, partial and full‐thickness dermal ulcers | FDA (2018) |
| Cutimed gel (BSN Medical) | Carbomer 940 | Wound dressing | Management of dry to low exuding wounds | FDA (2014) | |
| Woun'Dres (Coloplast) | Carbomer, collagen | Wound dressing | Dry wounds | FDA (1999) | |
| DermaSyn (DermaRite Industries) | Carbomer940 | Wound dressing | Management of acute or chronic partial and full thickness wounds/ulcers that are dry or have minimal exudate | FDA (2006) | |
| Suprasorb G (Lohmann & Rauscher Global) | CMC polymer, propylene glycol | Bandage | Dry wounds, lower leg ulcer, pressure ulcer, first and second‐degree burns, scalds | FDA (2016) | |
| DermaGauze™ (DermaRite industries) | Acrylate polymer | Hydrogel impregnated gauze | Acute or chronic partial and full thickness wounds | FDA (2014) | |
| Simpurity™ Hydrogel (Safe n'Simple) | Polyethylene oxide, polyvinyl alcohol, acrylate, polyurethane | Absorben sheet | Dry wounds, skin burns and dry scabs | FDA (2011) | |
| AquaDerm™ (DermaRite industries) | 2‐Acrylamido‐2 methyl‐1‐propanesulfonic acid sodium, propylene glycol, poly (ethylene glycol) dimethacrylate, 2‐hydroxy‐2‐methylpropiophenone | Hydrogel sheet | Pressure ulcers, minor burns and radiation tissue damage | FDA (2013) | |
| Wound dressing: natural | Hyalofill (Anika) | Hyaluronic acid | Wound care and treatment | Absorb wound exudate, promote granulation tissue formulation, supports healing process | FDA (1999) |
| HemCon bandage (HemCon Medical Technologies) | Chitosan | Bandage | Provide hemostatsis and antibacterial barrier | FDA (2003) | |
| Regenecare wound gel (MPM Medical) | Collagen, aloe and sodium alginate with lidocaine | Wound filling | Management of skin wounds | FDA (2002) | |
| Purilon® Gel (Coloplast) | Sodium carboxymethylcellulose, calcium alginate | Wound filling | Dry and sloughy necrotic wounds as well as wounds with a mix of necrotic and granulated tissue | FDA (1997) | |
| Prontosan wound gel (B. Braun Medical) | Glycerol, hydroxyethyl cellulose with polyhexamethylene biguanide and undecylenamidopropyl betaine | Would gel | Management of ulcers, burns, partial and full thickness wounds, large surface area wounds and surgical incisions | FDA (2013) | |
| Algicell Ag calcium alginate dressing with antimicrobial silver (Integra Life Science) | Calcium alginate with silver | Wound dressing | Abrasions and minor lacerations, cuts, scalds and burns | FDA (2008) | |
| INTRASITE gel hydrogel wound dressing (Smith & Nephew Healthcare) | Modified carboxymethyl cellulose, propylene glycol | Wound dressing | Re‐hydrates necrotic tissue, facilitating autolytic debridement, loosen and absorb slough and exudate | FDA (1990) | |
| SoloSite Gel (Smith & Nephew Healthcare) | Sodium carboxymethylcellulose | Wound dressing | Minor burns, superficial lacerations, cuts and abrasions (partial thickness wounds), skin tears, venous ulcers (leg ulcers), surgical incisions, diabetic foot ulcers | FDA (1998) | |
| NU‐GEL™ (Systagenix) | Sodium alginate | Wound dressing | Chronic wounds | FDA (1998) | |
| ActivHeal Hydrogel (Advanced Medical Solutions) | Alginate | Wound dressing | Rehydrates dry necrotic wounds | FDA (2001) | |
| Surgical Silver Post Operative Dressing (Advanced Medical Solutions) | Alginate with silver | Wound dressing | Post‐operative surgical wounds | FDA (2018) | |
| Tissue augmentation: synthetic | IDEAL IMPLANT Saline‐filled Breast Implant (Ideal Implant) | Silicone | Implant | Breast implant | FDA (2014) |
| MENTOR® MemoryShape® Breast Implants (J&J MedTech) | Silicone | Implant | Breast implant | FDA (2013) | |
| Natrelle 410 Highly Cohesive Anatomically Shaped Silicone‐Filled Breast Implant (Allergan) | Silicone | Implant | Breast implant | FDA (2013) | |
| Sientra Silicone Gel Breast Implants (Sientra, Inc.) | Silicone | Implant | Breast implant | FDA (2013) | |
| Others | ReSure sealent (Ocular Therapeutix) | PEG | Topical | Intraoperative management of clear corneal incisions | FDA (2014) |
| Progel™ Pleural Air Leak Sealant (NEOMEND, Inc.) | Human serum albumin (HSA) and polyethylene glycol (PEG) | Surgical implant | Seal air leaks in both open and minimally invasive thoracic surgery | FDA (2010) | |
| Plenity® (Gelesis, Inc.) | Cellulose and citric acid | Oral | Overweight, obesity | FDA (2019) | |
a
Products that were included in the 2020 “Hydrogels in the clinic” review.
Abbreviations: CE, Conformité Européenne mark in the European Union; EMA, European Medicines Agency; FDA, Food and Drug Administration; HPMC, hydroxypropyl methyl cellulose; PEG, poly(ethylene glycol); PLGA, poly(lactic‐co‐glycolic acid).