Dexamethasone intracanalicular insert may be effective for aqueous-deficient dry eye
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Key takeaways:
- Eyes with the insert had significantly less corneal and conjunctival staining at week 4, the latter of which continued through week 6.
- Eyes with the insert were more likely to have an increase in IOP.
A dexamethasone 0.4 mg intracanalicular insert was linked to greater improvement in corneal and conjunctival staining vs. a sham collagen plug among patients with aqueous-deficient dry eye, although it may increase IOP, research showed.
“Because of its efficacy in improving intraocular inflammation, we hypothesized that the dexamethasone intracanalicular insert could be advantageous for the short-term treatment of aqueous-deficient dry eye by helping to conserve tears as a tear duct plug, in addition to delivering sustained steroid release onto the ocular surface to combat inflammation,” Michael X. Lin, BA, a research coordinator at Wilmer Eye Institute, and colleagues wrote in Ophthalmology.
In a single-center, double-masked, randomized controlled trial, 75 adult patients (73% aged 50 years or older; 87% women) with clinically significant aqueous-deficient dry eye received a dexamethasone 0.4 mg intracanalicular insert with 30-day elution time in one eye and a sham collagen plug in the other. A masked investigator performed follow-up visits at weeks 2, 4 and 6 to evaluate the insert’s efficacy in treating dry eye.
At baseline, 47% of participants had visually significant cataracts, about 10% each had conjunctival scarring or punctal stenosis or significant corneal findings, and 36% already had punctal plugs. Among the most commonly used topical and oral medications were cyclosporine and immunosuppressive agents, respectively.
At week 4, eyes with the dexamethasone insert had significantly less corneal and conjunctival staining, the latter of which continued through week 6. These improvements at week 4 were greater among participants aged 60 years and older. In addition, Schirmer’s wetting was similar in both treatment arms at week 6.
There were no significant differences in any patient-reported symptoms, although patients at week 4 reported less dryness in the eye with the insert. Eyes with the insert also were more likely to have an increase in IOP at week 4, which resolved with short-term topical beta-blockers.
“This randomized controlled trial involving patients with clinically significant aqueous-deficient dry eye demonstrated that, compared with a traditional collagen plug, the dexamethasone 0.4-mg intracanalicular insert was associated with greater improvements in corneal and conjunctival staining scores at 4 weeks and greater improvement in conjunctival staining at 6 weeks, which is beyond the 30-day drug elution period, suggesting a beneficial anti-inflammatory effect of this treatment in addition to the tear-retaining effect by blocking the puncta,” Lin and colleagues wrote.
Editor's note: The headline for this article was revised on July 16, 2024, for accuracy. Healio regrets the error.
Perspective
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This trial found that the intracanalicular dexamethasone implant significantly improved corneal and conjunctival staining at 4 weeks. Additional findings included similar Schirmer’s scores and no statistically significant difference in patient-reported symptoms, although patients reported less dryness with the dexamethasone implant. Approximately 12% of eyes treated with the dexamethasone implant had an IOP spike of at least 5 mm Hg measurable at 4 weeks and were treated with short-term beta-blockers.
Another interesting finding was the responder analysis, which showed that eyes with improved corneal staining correlated with patients who reported less eye dryness symptoms, suggesting the potential for corneal staining as an objective measure for dry eye treatment efficacy.
While topical steroids are one treatment option for patients with dry eye, other classes of medication are also useful. Intracanalicular implants impregnated with other pharmacological agents, such as a soft steroid or cyclosporine/lifitegrast, an amniotic membrane or an antibiotic/steroid combination would form an interesting comparison model. Future studies of one eye receiving topical vs. intracanalicular dexamethasone also may be of value.
As reported by the authors, the dexamethasone implant is only FDA-approved for intraocular inflammation and eye pain occurring after cataract surgery, not for dry eye treatment.
As a dry eye specialist, I know the value of pulse treatments with dexamethasone, and an intracanalicular plug that dissolves in 30 days would be a great asset for my dry eye treatment options. However, the relative risk of increased IOP is concerning. Larger population studies are needed to rule out possible confounders, given the demographics of the population in the current study.
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