Dexamethasone Intracanalicular Insert: A Review in Treating Post-Surgical Ocular Pain and Inflammation

Abstract

Dextenza ® , an intracanalicular insert that is placed into the lower punctal opening of the eye, gradually releases dexamethasone for up to 30 days to alleviate pain and inflammation associated with ophthalmic surgery. A significantly higher proportion of patients treated with the dexamethasone intracanalicular insert than with the placebo insert had no pain at day 8 (co-primary endpoint, 7 days post-operation) across three pivotal phase III trials, and the inflammation co-primary endpoint (absence of anterior chamber cells) at day 14 (13 days post-operation) was met in two of three trials. Overall, the dexamethasone intracanalicular insert was effective and generally well tolerated for the treatment of post-surgical ocular pain and inflammation following cataract surgery. As low patient adherence is an issue for topical ophthalmic anti-inflammatory medications, the convenience (ease of insertion, single application with no patient input and typically no removal required) of the dexamethasone intracanalicular insert makes it a promising emerging option for the treatment of ocular inflammation and pain following ophthalmic surgery.

Phase 3 Randomized Study of Efficacy and Safety of a Dexamethasone Intracanalicular Insert in Patients With Allergic Conjunctivitis

“…Insertion by the physician assures treatment was rendered, and the procedure is relatively quick and minimally invasive and is optimal for the outpatient clinic setting. Pharmacologically, a single, hands-free, dexamethasone insert provides a sustained, tapered administration of corticosteroid to the ocular surface, in which drug is slowly released over up to 30 days, 28 thereby reducing the risk of rebound inflammation that can occur with abrupt discontinuation of steroid. 47 Future studies of the dexamethasone insert for the treatment of allergic conjunctivitis could potentially be expanded into specific subgroups such as children with allergies, because untreated allergic conjunctivitis can lead to ocular complications, particularly in this subpopulation.…”

“…The insert delivers a tapered release of 0.4 mg dexamethasone to the ocular surface in a sustained manner for up to 30 days. 27 The insert is resorbable and is cleared through the nasolacrimal duct, obviating the need for physician removal of the insert, 28 although it can be removed, if necessary. This dexamethasone insert was recently approved by the United States Food and Drug Administration (FDA) for the treatment of postoperative ocular pain and inflammation based on a favorable efficacy and safety profile among subjects undergoing cataract surgery.…”

Evaluation of Same-Day versus Next-Day Implantation of Intracanalicular Dexamethasone for the Control of Postoperative Inflammation and Pain Following Cataract Surgery

“…The sustained-release insert described herein offers attributes that overcome the potential side effects and challenges of topical corticosteroid use. 20 , 21 Topical agents, which are instilled intermittently, inevitably lead to variability in drug concentration owing to the poor bioavailability of the agent. The insert’s intracanalicular location, with proximity to the ocular surface, purports to offer a superior bioavailability profile with improved consistency of drug concentration in contrast to topical administration.…”

Plasma Pharmacokinetic Parameters of Dexamethasone Following Administration of a Dexamethasone Intracanalicular Insert in Healthy Adults

“…24 No changes in the conjunctiva, cornea, anterior chamber, iris, eyelid or lens were observed. Similar to the clinical trial experience, 30 investigators rated the dexamethasone insert as easy to place, visualize and remove when necessary.…”