You are here

New, One-Time Corticosteroid for Post-Surgical Ocular Pain Approved

Resorbable Dextenza is the First Intracanalicular Insert for Drug Delivery

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

More Headlines

BTC Is a Group of Rare Gastrointestinal Cancers With Limited Treatment Options, Poor Outcomes
Study Demonstrates Rapid Response in Patients, and Doesn’t Affect Tamoxifen Efficacy
Prescription App Can Serve As Training, Monitoring, and Reminder Tool
Patients with MS Suffered Stroke, Blood Vessel Tearing in Head and Neck After Receiving Drug
First Biosimilar For Adults With CD20-Positive, B-Cell Non-Hodgkin’s Lymphoma
Life-Threatening Side Effect of Drug for Acute Myeloid Leukemia
First Drug for Rare Autoimmune Disorder That Affects Nerve, Muscles Connection
Hope For Patients With Highly Aggressive Form of AML