FDA Officials OK Dextenza for Post-Ophthalmic Surgery Pain Management
Safety data came from both phase 3 studies as well as a phase 2 study of Dextenza, which together totaled 351 patients.
The US Food and Drug Administration (FDA) has approved Dextenza, a dexamethasone ophthalmic insert, for intracanalicular use for the treatment of ocular pain following ophthalmic surgery.
Dextenza is inserted in the lower lacrimal punctum and into the canaliculus. Once in place, the ophthalmic insert releases .4mg dexamethasone to reduce post-surgical pain for up to 30 days with a single administration. The device could replace current standard of care regimens that include up to 70 topical steroid-containing eye drops.
The FDA’s approval decision was supported by data from 2 randomized, vehicle-controlled phase 3 studies, which showed that a statistically significantly higher percentage of patients were pain free 8 days after cataract surgery with Dextenza than with the vehicle control.
In study 1, 80% of patients treated with Dextenza (n = 164) were pain free at day 8, compared to 43% of patients in the vehicle arm (n = 83) (P<.0001). In the second study, 77% (n=161) and 59% (n=80) of patients treated with Dextenza and vehicle were pain free after 8 days (P=.025).
Safety data came from both phase 3 studies as well as a phase 2 study of Dextenza, which together totaled 351 patients. The most common ocular adverse reactions 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%).
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