Dextenza offers rapid, sustained relief of pain and inflammation

Dual endpoints were met in a prospective, multicenter, randomized, double-masked phase 3 safety and efficacy study.

Patients who received an intracanalicular dexamethasone insert after cataract surgery experienced early, sustained relief of pain and inflammation, according to a study.

Dextenza (dexamethasone ophthalmic insert 0.4 mg, Ocular Therapeutix), which was FDA approved in December 2018, is indicated for the treatment of ocular pain after ophthalmic surgery and lasts up to 30 days with one treatment.

The insert offers consistent and tapered drug dosing after cataract surgery, study co-author Sydney L. Tyson, MD, MPH, told Ocular Surgery News.

Sydney L. Tyson, MD, MPH
Sydney L. Tyson

“Dextenza eliminates patient compliance concerns with a single preservative-free insert. By avoiding issues with patient noncompliance, Dextenza also eliminates any possibility of abrupt discontinuation of therapy that could cause ocular rebound inflammation,” he said.

The prospective, multicenter, double-masked phase 3 study evaluated the safety and efficacy of Dextenza compared with placebo for treatment of inflammation and pain after clear corneal cataract surgery. Two hundred fourteen patients were randomly assigned to receive Dextenza, and 221 patients were in the placebo control arm of the study, which ended at day 45.

The primary efficacy endpoints were absence of pain at postoperative day 8 and absence of anterior chamber cells at day 14.

At the endpoint dates, 79.6% of Dextenza patients had no ocular pain compared with 61.3% of placebo patients, and 52.3% of Dextenza patients had no anterior chamber cells compared with 31.1% of placebo patients, both statistically significant differences (P < .0001).

“The quick onset of action demonstrated by the volume of patients who were pain-free on postoperative day 1 was impressive,” Tyson said.

At each measured timepoint between day 4 and day 45, significantly more patients in the Dextenza arm had an absence of anterior cells compared with the placebo arm (P < .05). Additionally, the mean anterior chamber cell score in the Dextenza arm was lower than the placebo arm at all postoperative time points.

At postoperative day 2, the mean ocular pain score in the Dextenza arm was 0.6 units on a scale of 0 to 10; this declined to 0.2 units at the study’s end. At postoperative day 2 in the placebo arm, mean pain score was 1.2 units, which declined to 0.5 units at day 45.

Dextenza offers patients and practitioners other advantages as well.

For clinicians, a key factor is ease of use, with investigators rating the product as “easy” or “moderately easy” to insert in 98.9% of all eyes, Tyson said. Furthermore, the ability to visualize the insert increases confidence that medication is “onboard and under control.”

For patients with dry eye, the occlusion of the punctum beyond 30 days of treatment is an added benefit, he said.

In this and two previous similar studies, only one patient experienced an IOP increase attributable to the product, Tyson said. However, he added, for patients who may not respond well to the insert, Dextenza is easy to remove through manual expression or saline irrigation. – by Robert Linnehan

Disclosure: Tyson reports he received grant support from Ocular Therapeutix for the conduct of the study.

Patients who received an intracanalicular dexamethasone insert after cataract surgery experienced early, sustained relief of pain and inflammation, according to a study.

Dextenza (dexamethasone ophthalmic insert 0.4 mg, Ocular Therapeutix), which was FDA approved in December 2018, is indicated for the treatment of ocular pain after ophthalmic surgery and lasts up to 30 days with one treatment.

The insert offers consistent and tapered drug dosing after cataract surgery, study co-author Sydney L. Tyson, MD, MPH, told Ocular Surgery News.

Sydney L. Tyson, MD, MPH
Sydney L. Tyson

“Dextenza eliminates patient compliance concerns with a single preservative-free insert. By avoiding issues with patient noncompliance, Dextenza also eliminates any possibility of abrupt discontinuation of therapy that could cause ocular rebound inflammation,” he said.

The prospective, multicenter, double-masked phase 3 study evaluated the safety and efficacy of Dextenza compared with placebo for treatment of inflammation and pain after clear corneal cataract surgery. Two hundred fourteen patients were randomly assigned to receive Dextenza, and 221 patients were in the placebo control arm of the study, which ended at day 45.

The primary efficacy endpoints were absence of pain at postoperative day 8 and absence of anterior chamber cells at day 14.

At the endpoint dates, 79.6% of Dextenza patients had no ocular pain compared with 61.3% of placebo patients, and 52.3% of Dextenza patients had no anterior chamber cells compared with 31.1% of placebo patients, both statistically significant differences (P < .0001).

“The quick onset of action demonstrated by the volume of patients who were pain-free on postoperative day 1 was impressive,” Tyson said.

At each measured timepoint between day 4 and day 45, significantly more patients in the Dextenza arm had an absence of anterior cells compared with the placebo arm (P < .05). Additionally, the mean anterior chamber cell score in the Dextenza arm was lower than the placebo arm at all postoperative time points.

At postoperative day 2, the mean ocular pain score in the Dextenza arm was 0.6 units on a scale of 0 to 10; this declined to 0.2 units at the study’s end. At postoperative day 2 in the placebo arm, mean pain score was 1.2 units, which declined to 0.5 units at day 45.

Dextenza offers patients and practitioners other advantages as well.

For clinicians, a key factor is ease of use, with investigators rating the product as “easy” or “moderately easy” to insert in 98.9% of all eyes, Tyson said. Furthermore, the ability to visualize the insert increases confidence that medication is “onboard and under control.”

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For patients with dry eye, the occlusion of the punctum beyond 30 days of treatment is an added benefit, he said.

In this and two previous similar studies, only one patient experienced an IOP increase attributable to the product, Tyson said. However, he added, for patients who may not respond well to the insert, Dextenza is easy to remove through manual expression or saline irrigation. – by Robert Linnehan

Disclosure: Tyson reports he received grant support from Ocular Therapeutix for the conduct of the study.