Abstract:Aim: Despite advances in cataract surgery, postoperative ocular inflammation and pain occurs. To address compliance issues with topical corticosteroid administration, a hydrogel-based dexamethasone insert was developed for intracanalicular administration. The objective is to understand the anatomy to best administer the insert and learn how the anatomy and hydrogel properties help retain the insert in the canaliculus over time. Materials & methods: Human cadavers (n = 5) were dissected to assess dimensions… Show more
“…After the drug is eluted over 30 days, the hydrogel insert begins to slowly hydrolyze, eventually liquefying, then clearing the nasolacrimal system by flushing through the nasolacrimal duct. 18 In the rare case where removal of the insert is needed, manual expression or saline irrigation can be administered. 17 Figure 1 Placement of the Dexamethasone Intracanalicular Insert in the canaliculus of the eye.…”
Purpose
To describe the early real-world experience of physicians with an intracanalicular dexamethasone insert (DEX) in patients undergoing cataract surgery and to capture the clinical impact of adopting this therapy.
Patients and Methods
23 United States sites including Ambulatory Surgical Center Setting (ASC) and Outpatient Clinical settings. Respondents were physicians who had early experience with DEX in cataract surgery patients. This was a Phase 4 experiential cross-sectional survey study comprised of 3 sequential online physician surveys. Descriptive statistics summarized the surveys’ responses to determine the early impressions of the respondents.
Results
Forty-two physicians completed surveys. On average, physicians reported feeling comfortable administering DEX after placing 3 inserts (mean 2.7; standard deviation 1.9). Most physicians (92%) were satisfied with DEX, and all physicians (100%) reported that DEX improved patient compliance. Most physicians (62.5%) indicated they would highly prefer DEX over traditional steroid eyedrops for the management of post-surgical inflammation and pain.
Conclusion
The surveys exploring the early use of DEX suggest that DEX is a clinically effective treatment with a rapid initial learning curve and integrates well into clinical use. Physicians had a very positive early experience with DEX, including comfort with insertion and satisfaction. DEX shows promise as a primary treatment choice of physicians for ocular inflammation and pain following cataract surgery by offering patients a hands-free innovative therapy that delivers a preservative-free steroid to the ocular surface over approximately 30 days.
“…After the drug is eluted over 30 days, the hydrogel insert begins to slowly hydrolyze, eventually liquefying, then clearing the nasolacrimal system by flushing through the nasolacrimal duct. 18 In the rare case where removal of the insert is needed, manual expression or saline irrigation can be administered. 17 Figure 1 Placement of the Dexamethasone Intracanalicular Insert in the canaliculus of the eye.…”
Purpose
To describe the early real-world experience of physicians with an intracanalicular dexamethasone insert (DEX) in patients undergoing cataract surgery and to capture the clinical impact of adopting this therapy.
Patients and Methods
23 United States sites including Ambulatory Surgical Center Setting (ASC) and Outpatient Clinical settings. Respondents were physicians who had early experience with DEX in cataract surgery patients. This was a Phase 4 experiential cross-sectional survey study comprised of 3 sequential online physician surveys. Descriptive statistics summarized the surveys’ responses to determine the early impressions of the respondents.
Results
Forty-two physicians completed surveys. On average, physicians reported feeling comfortable administering DEX after placing 3 inserts (mean 2.7; standard deviation 1.9). Most physicians (92%) were satisfied with DEX, and all physicians (100%) reported that DEX improved patient compliance. Most physicians (62.5%) indicated they would highly prefer DEX over traditional steroid eyedrops for the management of post-surgical inflammation and pain.
Conclusion
The surveys exploring the early use of DEX suggest that DEX is a clinically effective treatment with a rapid initial learning curve and integrates well into clinical use. Physicians had a very positive early experience with DEX, including comfort with insertion and satisfaction. DEX shows promise as a primary treatment choice of physicians for ocular inflammation and pain following cataract surgery by offering patients a hands-free innovative therapy that delivers a preservative-free steroid to the ocular surface over approximately 30 days.
“…15 The dexamethasone hydrogel insert is fluorescein-conjugated to aid with visualization. 16 Large placebo-controlled studies have demonstrated the efficacy of the insert for alleviating inflammation and pain following cataract surgery 17,18 leading to FDA approval for the treatment of ocular inflammation and pain following ophthalmic surgery. 19 Patients treated with the dexamethasone insert reported favorably on overall satisfaction, convenience and comfort.…”
Intracanalicular dexamethasone insert is a resorbable sustained-release polyethylene glycol-based hydrogel insert delivering a 0.4 mg tapered dose of dexamethasone for up to 30 days to the ocular surface. It is FDA-approved for treating inflammation and pain after ocular surgery. It has also been studied for ocular surface diseases such as allergic conjunctivitis. This study assessed the plasma pharmacokinetic (PK) parameters of dexamethasone following intracanalicular insertion. Patients and Methods: Study subjects (N=16) were healthy adults. A dexamethasone insert was unilaterally placed into the canaliculus, and blood samples were obtained for analysis 1 hour prior to insertion and 1, 2, 4, 8, 16, 24 hours and 4, 8, 15, 22 and 29 days after insertion. Safety analyses included slit lamp and dilated fundus examinations, best corrected visual acuity, intraocular pressure (IOP) and adverse events (AEs). Results: Plasma results were below the lower limit of quantitation (LLOQ) at all time points in five subjects (31.3%). Among subjects with quantifiable plasma concentrations, C max was <1 ng/mL (range, 0.05 to 0.81 ng/mL), AUC 0-last ranged from 0.13 to 7.18 h•ng/mL, and T max ranged from 4.0 to 163.0 hours. Mean (SD) IOP increased from 16.3 (1.4) mmHg at baseline to 19.3 (3.2) at Day 22 but returned to baseline after treatment. No changes occurred in dilated fundus, punctum, or visual acuity examinations.
Conclusion:The dexamethasone 0.4 mg insert results in minimal systemic exposure following intracanalicular administration.
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