Dextenza (Ocular Therapeutix) is a biodegradable intracanalicular insert containing 0.4 mg of preservative-free dexamethasone. The drug is encapsulated in a polyethylene glycol (PEG) hydrogel and designed to provide a tapered release of dexamethasone over 30 days.
It received FDA approval in 2018 and 2019 for the treatment of pain and inflammation after ophthalmic surgery, and in 2021 its indication was expanded to include treatment of ocular itching associated with allergic conjunctivitis4).
With eye drop therapy, less than 5% of the drug reaches intraocular tissues due to precorneal loss and the corneal epithelial barrier1). Noncompliance with eye drops reaches approximately 30%, and 92% of post-cataract surgery patients have been reported to use improper instillation techniques1). Dextenza resolves these adherence issues and enables continuous, consistent steroid delivery as a drug delivery system (DDS)1).
Features of Dextenza
Dosage form: Cylindrical insert approximately 0.5 mm in diameter and 3 mm in length
Content: Dexamethasone 0.4 mg
Release duration: Gradual release over 30 days
Material: PEG hydrogel (visible due to fluorescein binding)
Degradation: Liquefies via hydrolysis and is naturally expelled through the nasolacrimal duct
Challenges of conventional eye drop therapy
Bioavailability: Less than 5% of the drug reaches the eye 1)
Adherence: Non-compliance rate approximately 30% 1)
Administration errors: 92% of patients perform improper eye drop instillation 1)
Concentration fluctuations: Repeated peaks immediately after instillation and troughs before the next dose 1)
Preservative toxicity: Risk of damage to the ocular surface 1)
Dextenza is a small insert (0.5 mm in diameter, 3 mm in length) placed into the punctum and canaliculus, which releases 0.4 mg of dexamethasone over 30 days. Made of PEG hydrogel and preservative-free, it naturally degrades and is expelled after about 30 days, eliminating the need for removal. It is FDA-approved for inflammation and pain after ophthalmic surgery and for ocular itching associated with allergic conjunctivitis. By occluding the canaliculus, it may also provide a lubricating effect similar to a punctal plug.
| Category | Target |
|---|---|
| Indication | Inflammation and pain after ophthalmic surgery |
| Indications | Ocular itching due to allergic conjunctivitis |
| Contraindications | Active infection of the cornea, conjunctiva, or lacrimal canaliculus |
| Contraindications | Fungal infection or dacryocystitis |
It is a useful option for patients with physical or mental limitations that make eye drop instillation difficult, those at high risk of inflammation such as uveitis, and those with severe dry eye. Dextenza also functions as a punctal plug by occluding the lacrimal canaliculus, thereby suppressing tear drainage.
Dexamethasone is a potent corticosteroid. It suppresses inflammatory cytokines such as interleukin-1 (IL-1), tumor necrosis factor (TNF), interferon-gamma (IFN-γ), and granulocyte-macrophage colony-stimulating factor (GM-CSF), reducing neutrophil migration, capillary permeability, and edema.
Drug release from Dextenza is sustained and gradually decreasing, without the peak and trough fluctuations seen with intermittent eye drop administration 1). In healthy volunteers, plasma dexamethasone concentrations were detected in only 11% of all samples (0.05–0.81 ng/mL), indicating minimal systemic effects.
If the hydrogel absorbs water before insertion, use a new insert. It liquefies by hydrolysis after about 30 days and is usually excreted through the nasolacrimal duct, so removal is generally unnecessary. If needed, it can be removed by irrigation with saline or manual expression.
After dilating the punctum with a dilator, insert it into the canaliculus through the lower punctum using non-toothed forceps. It is important to dry the area around the punctum before insertion to prevent the hydrogel from swelling. Because it is a fluorescein-tagged hydrogel, placement can be confirmed with blue light and a yellow filter. It usually degrades and is excreted after about 30 days, so removal is generally unnecessary, but if needed, it can be removed by saline irrigation or manual expression.
In a prospective randomized contralateral eye comparison study (41 patients), the dropless regimen (Dextenza + intracameral ketorolac + intracameral moxifloxacin) was compared with conventional eye drop therapy 1). There were no significant differences between the two groups in pain resolution rate, SOIS (anterior chamber inflammation score), corrected distance visual acuity (CDVA), or IOP 1).
94.7% of patients preferred the dropless regimen, and patient-reported out-of-pocket costs were reduced by an average of $158 1). The control group required more than 250 eye drops over one month, whereas the dropless group required zero drops 1).
Post-Cataract Surgery Study
Design: Prospective contralateral eye RCT, 41 patients 1)
Pain resolution rate (1 month): 100% in both groups 1)
Patient preference: 94.7% preferred dropless 1)
Cost difference: Average savings of $158 (dropless group) 1)
Allergic Conjunctivitis Phase 3 Trial
Design: Multicenter double-blind RCT, 96 patients 4)
Primary endpoint: Itching score on Day 8 4)
Results: P<0.0001 at all time points (3, 5, 7 minutes) 4)
Conjunctival hyperemia: DEX superior at all 18 evaluation time points 4)
In a Phase 3 randomized, double-blind, placebo-controlled trial (96 patients), the efficacy of Dextenza was evaluated using the conjunctival allergen challenge (CAC) model 4). On Day 8, 7 days after insertion, itching scores were significantly lower than placebo at all time points (3, 5, and 7 minutes; difference -0.86 to -0.98, P<0.0001) 4), and conjunctival hyperemia was also significantly better in the DEX group at all 18 evaluation time points 4). No IOP elevation, canaliculitis, or rescue medication use was reported 4).
In a real-world comparative trial (30 patients), Dextenza was significantly superior to topical steroid (loteprednol) in improving itching and hyperemia (P=0.009, P=0.0004), and 66.7% of patients preferred it 2). However, in comparison with topical antihistamine (olopatadine), efficacy was equivalent, and no clear preference was observed 2).
In a randomized prospective trial of 30 eyes after penetrating keratoplasty, DSEK, or DMEK, Dextenza plus a low-frequency topical regimen was compared with a conventional high-frequency topical regimen 3). There were no significant differences between the two groups in pain scores, anterior chamber inflammation, IOP elevation, corneal rejection, or cystoid macular edema (CME) 3). No patient required steroid rescue 3).
| Indication | Design | Primary Outcome |
|---|---|---|
| Post-cataract surgery 1) | Contralateral eye RCT, 41 patients | Equivalent to drops, 94.7% preferred |
| Allergic conjunctivitis4) | Phase 3 RCT, 96 patients | Itching score P<0.0001 |
| Post-keratoplasty3) | Prospective RCT, 30 eyes | Safety comparable to standard treatment |
The main advantage of Dextenza is that it provides sustained drug release over 30 days, eliminating adherence issues. In clinical trials after cataract surgery, it showed anti-inflammatory and analgesic effects comparable to conventional eye drop regimens (over 250 drops per month) and was preferred by 94.7% of patients. Being preservative-free reduces ocular surface toxicity, and it also provides tear retention effects due to punctal occlusion. Patient out-of-pocket costs were reduced by an average of $158. However, monitoring is necessary due to the risk of IOP elevation and canaliculitis.
After corneal transplantation, frequent steroid eye drops are required, and adherence is particularly challenging in elderly patients3). The finding that Dextenza combined with a low-frequency eye drop regimen showed safety comparable to standard treatment is a promising insight that may reduce the burden of postoperative steroid management3). Future studies will explore additional insert placement after the initial insert dissolves to further reduce the need for eye drops beyond one month postoperatively3).
Non-adherence to eye drops in glaucoma is known to correlate with progression of visual field damage2). The concept of sustained-release DDS like Dextenza may be applied to delivery systems for glaucoma medications in the future2).
- Donnenfeld ED, Hovanesian JA, Malik AG, Wong A. A Randomized, Prospective, Observer-Masked Study Comparing Dropless Treatment Regimen Using Intracanalicular Dexamethasone Insert, Intracameral Ketorolac, and Intracameral Moxifloxacin versus Conventional Topical Therapy to Control Postoperative Pain and Inflammation in Cataract Surgery. Clin Ophthalmol. 2023;17:2349-2356.
- Reich S, Lopez M, Leff J, Herman J. DEXTENZA versus Topical Steroid or Antihistamine Therapy for Treatment of Allergic Conjunctivitis. Clin Ophthalmol. 2024;18:473-480.
- Alsetri H, Fram N, Shiler O. Evaluating a Sustained-Release Dexamethasone Insert as Adjunctive Therapy for Inflammation and Pain Post-Corneal Transplantation. Clin Ophthalmol. 2024;18:2083-2091.
- Kenyon K, McLaurin EB, Silverstein SM, et al. A Randomized, Multicenter Phase 3 Clinical Trial Evaluating Intracanalicular Dexamethasone Insert for the Treatment of Allergic Conjunctivitis. Clin Ophthalmol. 2024;18:2671-2684.
