FDA OKs Steroid Insert (Dextenza) for Postop Ocular Pain

Megan Brooks

Disclosures

December 03, 2018

The US Food and Drug Administration has approved the first intracanalicular insert that delivers dexamethasone (Dextenza, Ocular Therapeutix) to treat ocular pain following ophthalmic surgery, the company has announced.

Dextenza, inserted in the lower lacrimal punctum and canaliculus, releases 0.4 mg dexamethasone for up to 30 days following insertion. Dextenza is resorbable and does not need to be removed. Saline irrigation or manual expression can be performed to remove the insert if necessary.

"Compliance with taking eye drops after eye surgery is very challenging for patients and a concern for surgeons," Michael Goldstein, MD, chief medical officer for Ocular Therapeutix, said in a news release.

"The approval of Dextenza offers surgeons the opportunity to treat patients with a preservative-free steroid after surgery with the placement of a single drug insert. With this product, patients may be liberated from having to deal with the burdensome regimen of using steroid eye drops after ophthalmic surgery," said Goldstein.

Dextenza was assessed in two randomized, multicenter, double-blind, phase 3 trials in which patients received the Dextenza insert or vehicle immediately after cataract surgery.

In both studies, significantly more patients treated with the Dextenza insert than with vehicle were pain free on postoperative day 8 (study one: 80% vs 43%; P < .001; study two: 77% vs 59%; P = .025).

The most common ocular adverse reactions in patients treated with Dextenza were anterior chamber inflammation including iritis and iridocyclitis (9%), increased intraocular pressure (5%), reduced visual acuity (2%), eye pain (1%), cystoid macular edema (1%), corneal edema (1%), and conjunctival hyperemia (1%). The most common non-ocular adverse event was headache (1%).

Dextenza is contraindicated in patients with active corneal, conjunctival, or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, fungal diseases of the eye, and dacryocystitis.

Complete prescribing information is available online.

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