Dextenza shows rapid, effective reduction of postoperative inflammation, pain
A pooled post hoc analysis of phase 3 studies showed rapid and consistent efficiency of Dextenza in the treatment of post-cataract inflammation and pain.
The results, presented at the virtual American Academy of Ophthalmology annual meeting, suggest that “this new option could obviate the need for corticosteroid drops, providing tapered therapy over 30 days,” Francis S. Mah, MD, said.
Corticosteroid drop regimens are the mainstay of cataract surgery to manage pain and inflammation, but they are complex and depend on patient compliance.
“As a component of a regimen that can include up to 70 eye drops over 4 weeks, they can create a burden for patients, physicians and practices,” he said.
The phase 3 studies involved more than 50 sites in the U.S. and enrolled 926 subjects randomly assigned to receive Dextenza (dexamethasone ophthalmic insert 0.4 mg, Ocular Therapeutix) or placebo after cataract surgery. NSAIDs were not prescribed in either group. In the post hoc analysis, cumulative drug effect and time to resolution of inflammation and pain were evaluated.
“The mean scores showed statistically significant difference in favor of Dextenza as early as day 4 for inflammation and day 2 for pain,” Mah said. “The area under the curve outcomes suggest consistency of the drug effect benefits over 30 days. Inflammation resolved twice as fast with Dextenza as compared with placebo at day 7 vs. day 14, and pain resolved at day 4 vs. placebo at day 14 in the 75th percentile population.”
Further studies comparing Dextenza with other steroid eye drops are currently being conducted.
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Mah FS, et al. Magnitude of cumulative drug effect and time to resolution with an intracanalicular dexamethasone insert (0.4 mg) in pooled phase 3 studies. Presented at: American Academy of Ophthalmology annual meeting; Nov. 13-15, 2020 (virtual meeting).
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