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New, One-Time Corticosteroid for Post-Surgical Ocular Pain Approved
Dextenza (dexamethasone ophthalmic insert, Ocular Therapeutix) is the first FDA-approved, single-administration insert for eye pain after ophthalmic surgery. The new, preservative-free drug has the potential to replace the current, complex eye-drop regimen, which necessitates administering up to 70 topical steroid drops.
Because compliance with taking eye drops after ophthalmic surgery has proved very challenging for patients and is a concern for surgeons, it is hoped that dexamethasone ophthalmic insert will free patients from a burdensome regimen. The single 0.4-mg dose is released over 30 days and does not require removal as it is resorbable.
In two randomized, multicenter, double-masked, parallel-group, vehicle-controlled, phase 3 clinical trials, patients receiving dexamethasone ophthalmic insert following cataract surgery showed a statistically significant improvement in pain.
The most common ocular adverse reactions to the drug were anterior chamber inflammation including iritis and iridocyclitis, increased intraocular pressure, reduced visual acuity, eye pain, cystoid macular edema, corneal edema, and conjunctival hyperemia. The most common non-ocular adverse event was headache.
The drug is contraindicated in patients with active corneal, conjunctival, or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella; mycobacterial infections; fungal diseases of the eye; and dacryocystitis. For any persistent corneal ulceration, fungal invasion must be considered and a fungal culture taken when appropriate.
Source: Ocular Therapeutics, December 3, 2018