Cataract surgery can provide patients with excellent visual acuity, but poor adherence with the postoperative eye drop regimen can negatively affect outcomes. This is a particular problem among patients with comorbidities for whom the addition of postoperative medications expands the complexity of their drug regimen. These concerns have driven efforts to simplify the postoperative routine.
In late 2018, Dextenza (dexamethasone ophthalmic insert 0.4 mg, Ocular Therapeutix) was approved by the FDA to treat ocular pain following ophthalmic surgery. The preservative-free insert replaces topical medications with a consistent and tapered dose of drug delivered to the ocular surface for up to 30 days.
The intracanalicular insert is introduced through the punctum and into the canaliculus. After delivering dexamethasone for 30 days, the insert softens, resorbs, and exits through the nasolacrimal system. The insert is conjugated with fluorescein, facilitating its visualization under blue light with a yellow filter. If a patient develops a steroid response, the surgeon can remove the insert either with saline irrigation or manual expression.
Dextenza can replace about 70 corticosteroid drops a patient would have taken in 30 days.1,2 The phase 3 FDA-approval data3,4 were robust: A statistically significantly higher incidence of treated patients reported being pain free 8 days after cataract surgery compared to the vehicle control group. The insert was safe, and patients rated it as comfortable.5
Ocular Therapeutix is looking to expand Dextenza’s current indication to include ocular inflammation after ophthalmic surgery. The FDA has set a Prescription Drug User Fee Act target action date of November 10 for its review of the supplemental new drug application. In supporting data, the insert demonstrated statistically significant superiority compared to the control vehicle in terms of absence of ocular pain at day 8 and absence of inflammation at day 14. Also at day 14, significantly more treated patients did not exhibit anterior chamber cell death compared with patients who received the placebo (52.3% vs 31.1%).
The study also demonstrated a quick onset of action, with 73% (n = 157) of patients reporting no pain on postoperative day 1. IOP elevation occurred in only one of 538 patients across all three phase 3 studies; the increase was related to the insert. Ocular Therapeutix applied for transitional pass-through payment status and a J-code with the CMS and recently announced receipt of a preliminary recommendation for a J-code that would take effect in January 2020.
Sydney Tyson, MD, MPH
- Eye Associates and SurgiCenter of Vineland, New Jersey
- Financial disclosure: Principal investigator for Dextenza (Ocular Therapeutix)