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Exclusives

Real-world experience shows intracanalicular dexamethasone insert easy to incorporate into practice, clinically beneficial

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The insert provides convenience for patients by eliminating the adherence burden of corticosteroid drops and offers flexibility of use for surgeons.

By Cynthia Matossian, MD, FACS

Corticosteroid drops prescribed in a tapered regimen are part of what could be called the “holy triad” of postoperative cataract surgery care along with antibiotics and nonsteroidal anti-inflammatory drugs.1 Undoubtedly effective when properly dosed, the steroidal drops present certain challenges to patients and to physicians in the clinical setting that can negatively affect outcomes. These factors include patient compliance, patient self-administration issues, an increased load of preservatives on the ocular surface, and burden to patients, physicians, and staff.2-4

Steroid Drop Adherence Burdensome
Suboptimal drop adherence is a well-documented concern; however, compliance with corticosteroid drops is even more problematic than with other types of drops due to the complex dosing regimen and repeated daily administration.2,4-6 If it is the second eye that is undergoing surgery a week or two after the first, there is a disconnect between the schedules of eye one and eye two making the patient administered treatment a burden even greater and more complicated.

Another factor limiting compliance is difficulty with patient administration of eyedrops itself, particularly in elderly patients who may have tremors, manual dexterity impairments, and memory issues.4 Incorrect self-administration occurs in more than 90% of patients after cataract surgery, which can potentially injure the ocular surface and negatively impact surgical recovery.4 Further, incorrect administration may result in contamination of the bottle, increasing the risk of infection.3 A prospective, cross-sectional study of 54 patients found that 92.6% of patients overestimated their level of compliance and proper drop-instillation technique.3

There is also a burden on the practice itself associated with prescribing this drop regimen. An enormous number of callbacks from pharmacies result from confusion over branded products and generic substitutions, plus educating patients on proper drop usage is time consuming for the physician and staff. Lindstrom et al estimated that 3,000 staff hours are spent annually on phone calls related to cataract surgery eyedrops.7 This is particularly noteworthy at a time when so many practices are experiencing personnel shortages.

Eliminating the Compliance Variable
Addressing these challenges has driven pharmaceutical companies to develop novel types of drops as well as dropless therapies.8-15 One of these is an FDA approved sustained-release dexamethasone hydrogel-based intracanalicular insert (Dextenza; dexamethasone ophthalmic insert, 0.4 mg; Ocular Therapeutix, Inc) indicated for inflammation and pain after ophthalmic surgery and ocular itching associated with allergic conjunctivitis.10 It was designed to replace traditional corticosteroid eyedrops, the insert is physician administered and thereby can remove patient issues of adherence, compliance, and potential for misuse or overuse.

As has been previously discussed, the sustained-release intracanalicular dexamethasone insert has shown robust inflammation and pain control and clinically relevant efficacy and safety.9,16,17 In order to understand the real-world usage of the insert in clinical practice, we wanted to capture the impact of adopting this therapy into clinical practice with regard to surgeon expectations, procedural experience, preferences, practice burden, and overall satisfaction. To do this we surveyed physicians who had early experience with the Dextenza insert in cataract surgery from 23 United States sites including ambulatory surgical centers and outpatient clinical settings. This Phase 4 experiential cross-sectional survey study was comprised of three sequential online physician questionnaires completed by 42 physicians.18

The study found that surgeons felt comfortable administering the insert after a mean of 2.7 insertions (range 1-10; standard deviation 1.9), and most—90%—rated their experience using the product as comfortable (a score of 5, 6, or 7 on a 7-point Likert scale). Most physicians (87%) also rated their overall experience with administration of the insert after initial experience as easy (5, 6, or 7 on a 7-point Likert scale). Only one physician rated the overall experience with the product’s administration to be difficult, which was due to the insert swelling immediately after contact with moisture.

The physicians were also surveyed about the practice’s incremental time burden with regard to implementing the insert. Most physicians (86%) responded that the use of the product had little to no incremental burden on staff time and logistics. After their initial experience, 92% of surveyed physicians were satisfied with using the inserts. Their perceptions were similar at the conclusion of the study, with 91% being satisfied. Further, 92% of physicians described patients as being accepting of receiving this dexamethasone product.

The survey found that 78.4% of respondents inserted the product in the ASC at the end of surgery, 8.1% placed it at the beginning of surgery, 2.7% immediately before the surgery in the office setting, and 10.8% placed it the next day in the office.

In the survey, physicians reported using the insert in patients with ocular comorbidities. Specifically, at least one comorbidity was present in 58.0% of the patient population with the most common being a history of dry eye disease (30%, n = 80).

Conclusion
The results of this study support the real-world practice benefits for physicians, with it taking a short time to become comfortable placing the intracanalicular insert. Respondents were satisfied with their experience and, importantly, the time burden on physicians and staff was negligible making it straightforward to integrate into practice. Using the Dextenza insert helps make patients’ postoperative journey smoother and hassle-free.

For surgeons, a major advantage of the insert is flexibility. Surgeons have the choice of placing it into the canaliculus in the ASC or in the office at the slit lamp and it also has wide applicability for any ocular surgical procedure. It can be used in conjunction with minimally invasive glaucoma surgery, post-pterygium surgery, and corneal surface refractive procedures like LASIK and PRK. If a surgeon encounters a particularly complex case requiring additional intraocular acrobatics that might lead to excessive inflammation, he or she can supplement the dexamethasone insert with a topical steroid if necessary.

Cynthia Matossian, MD, FACS is Founder and past Medical Director, Matossian Eye Associates, Pennsylvania and New Jersey
Contact: [email protected]
Financial disclosure: Consultant to Ocular Therapeutix

Reference

  1. Weiner G. Savvy steroid use. Eyenet Web site. Available from: https://www.aao.org/eyenet/article/savvy-steroid-use. Accessed October 10, 2021.
  2. Newman-Casey PA, Robin AL, Blachley T, et al. The most common barriers to glaucoma medication adherence: a cross-sectional survey. Ophthalmology. 2015;122(7):1308–1316. doi: 10.1016/j.ophtha.2015.03.026.
  3. An JA, Kasner O, Samek DA, et al. Evaluation of eyedrop administration by inexperienced patients after cataract surgery. J Cataract Refract Surg. 2014;40(11):1857-1861. doi: 10.1016/j.jcrs.2014.02.037
  4. Cataract Surgeons for Improved Eyecare. Analysis of the economic impacts of dropless cataract therapy on Medicare, Medicaid, state governments, and patient costs. Available from: http://stateofreform.com/wp-content/uploads/2015/11/CSIE_Dropless_Economic_Study.pdf. Accessed October 10, 2022.
  5. Durezol (difluprednate ophthalmic emulsion) [package insert]. East Hanover, New Jersey: Novartis Pharmaceuticals; 2020.
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  7. Lindstrom RL, Galloway MS, Grzybowski A, et al. Dropless cataract surgery: an overview. Curr Pharm Des. 2017;23(4):558-564. doi: 10.2174/1381612822666161129150628.
  8. Bausch Health Companies Inc. Bridgewater, New Jersey: Bausch + Lomb announces FDA approval of LOTEMAX SM (lotedprednol etabonate ophthalmic gel) 0.38% for the treatment of postoperative inflammation and pain following ocular surgery [press release]. Available from: https://www.prnewswire.com/news-releases/bausch–lomb-announces-fda-approval-of-lotemax-sm-loteprednol-etabonate-ophthalmic-gel-0-38-for-the-treatment-of-postoperative-inflammation-and-pain-following-ocular-surgery-300800968.html. Accessed October 10, 2022.
  9. Ocular Therapeutix. Bedford, MA: ocular Therapeutix announces FDA approval of supplemental new drug application (sNDA) for DEXTENZA (0.4 dexamethasone intracanalicular insert for ophthalmic use) for the treatment of ocular inflammation following ophthalmic surgery [press release]. Available from: https://ocutx.gcs-web.com/node/9551/pdf. Accessed October 10, 2022.
  10. EyePoint Pharmaceuticals. Watertown, MA: eyePoint Pharmaceuticals announces U.S. commercial launch of DEXYCU (dexamethasone intraocular suspension) 9% [press release]. Available from: https://www.globenewswire.com/news-release/2019/03/12/1752163/0/en/EyePoint-Pharmaceuticals-Announces-U-S-Commercial-Launch-of-DEXYCU-dexamethasone-intraocular-suspension-9.html. Accessed October 10, 2022.
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  14. Kushwaha SK, Saxena P, Rai A. Stimuli sensitive hydrogels for ophthalmic drug delivery: a review. Int J Pharm Investig. 2012;2(2):54-60. doi: 10.4103/2230-973X.100036.
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  16. Tyson SL, Bafna S, Gira JP, et al. Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2019;45(2):204-212. doi: 10.1016/j.jcrs.2018.09.023.
  17. Walters T, Bafna S, Vold S, et al. Efficacy and safety of sustained release dexamethasone for the treatment of ocular pain and inflammation after cataract surgery: results from two phase 3 studies. J Clin Exp Ophthalmol. 2016;7(4):572. doi: 10.4172/2155-9570.1000572 [CrossRef] [Google Scholar]
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