Eyeworld

improving the cataract patient experience: Minimizing pain and inflammation while reducing the need for topical drops 4 | SUPPLEMENT TO EYEWORLD | DECEMBER 2019 Bridging the gap: Dexamethasone punctal insert Alice Epitropoulos, MD I n the last several years, we have had multiple advance- ments in cataract surgery technology. However, until recently, we have had an unmet need for delivering medications to the eye postoperatively. New drug delivery systems are a major step forward. Overcoming challenges Patient adherence to topical regimens is poor, but the new dexamethasone intracanalicular insert is an innovative route of administration and one of the surgeon-controlled solu- tions we can offer our patients. The insert is a corticosteroid indicated to treat postop pain and inflammation after ocular surgery, reducing patient error and nonadherence. It delivers a tapered dose of dexamethasone over a peri- od up to 30 days; investigators rated it as easy to insert; and it resorbs following treatment. 1–3 Furthermore, it is conjugated with fluorescein to assist in visualization. The dexamethasone insert received FDA approval in November 2018 for the treat- ment of ocular pain following ophthalmic surgery. In June 2019, the FDA approved a supplemental New Drug Ap- plication with the addition of treatment of ocular inflamma- tion to its indication. All three trials showed the device was safe and well toler- ated, with a low incidence of increased intraocular pressure. Patients reported highly favorable outcomes in comfort, convenience, and satisfaction. 5 Conclusion Innovative drug delivery systems will improve patient By Alice Epitropoulos, MD Pooled efficacy results from three Phase 3 clinical trials for postop pain and inflammation Source: Data from Tyson et al. 4 *Statistically significant; P ≤ 0.0001 ITT-LOCF Population Absence of pain Day 8 Absence of anterior chamber cells Day 14 Proportion of patients with a score of 0 in the study eye Dexamethasone insert Placebo * 79.2% 56.9% * 42.7% 27.5% n=539 n=385 n=539 n=385 compliance and reduce ocular toxicity. Manufacturers are working on additional technolo- gies to eliminate nonadherence and treat other conditions. n References 1. Sawhney AS, Jarrett P, Bassett M, Blizzard C, inventors; Incept, LLC, assignee. Drug delivery through hy- drogel plugs. US patent 8,409,606 B2. April 2, 2013. 2. DEXTENZA [package insert]. Bed- ford, MA: Ocular Therapeutix Inc; 2018. 3. Walters TR, 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;7:572. This drug delivery system is preservative-free and the punctal occlusion provided by the insert may also benefit patients with dry eye. Three Phase 3 prospective, randomized, double-masked, vehicle-controlled trials eval- uated the safety and efficacy of the dexamethasone insert in 926 patients having cataract surgery. 3,4 In each Phase 3 study, more patients treated with the insert were pain-free at day 8 and had absent anterior cham- ber cells at day 14 vs. placebo. In one trial, the difference of absent anterior chamber cells at day 14 vs. placebo was not statistically significant. continued on page 5

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