Ocular Therapeutix has announced the launch of Dextenza (dexamethasone ophthalmic insert) for the treatment of ocular inflammation and pain following ophthalmic surgery.
The Company originally received Food and Drug Administration (FDA) approval for the treatment of ocular pain in November 2018 followed by the approval of a supplemental New Drug Application (sNDA) in June 2019 for the treatment of ocular inflammation.
Dextenza, a corticosteroid, is the first FDA-approved resorbable, intracanalicular insert. It is intended to be inserted in the lower lacrimal punctum into the canaliculus and does not require removal. It releases a 0.4mg dose of dexamethasone for up to 30 days following insertion.
Regarding safety, the most common treatment-emergent adverse events in clinical trials included anterior chamber inflammation including iritis and iridocyclitis (10%), increased intraocular pressure (6%), reduced visual acuity (2%), cystoid macular edema (1%), corneal edema (1%), eye pain (1%), and conjunctival hyperemia (1%). The most common non-ocular adverse event was headache (1%).
According to the Company, a unique billing code (C9048) was activated on July 1 2019 to facilitate reimbursement of Dextenza.
For more information visit dextenza.com.