The FDA has approved Dextenza, a dexamethasone ophthalmic insert, for the treatment of ocular pain following ophthalmic surgery.
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.
“Compliance with taking eye drops after eye surgery is very challenging for patients and a concern for surgeons,” said Michael Goldstein, MD, Chief Medical Officer, Ocular Therapeutix, in a statement. “The approval of Dextenza offers surgeons the opportunity to treat patients with a preservative-free steroid after surgery with the placement of a single drug insert. With this product, patients may be liberated from having to deal with the burdensome regimen of using steroid eye drops after ophthalmic surgery.”
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%).
“We are extremely pleased to announce the approval of Dextenza, coming so soon after our pre-approval inspection and approximately one month ahead of the PDUFA date,” said Antony Mattessich, Ocular Therapeutix's president and Chief Executive Officer. “We believe this approval is a major external validation of the drug delivery technology platform, and also of the transformation that has taken place at Ocular. While we are excited by the approval of our first drug product, our goal has always been to bring Dextenza to as many patients as possible in the near term and to revolutionize ophthalmic drug delivery by making drops obsolete. We now turn our efforts towards the successful commercial launch of Dextenza.”