Intracanicular insert is the first physician-administered, preservative-free method.
Reviewed by Dr Steven Silverstein.
The United States Food and Drug Administration (FDA) has approved the supplemental new drug application for dexamethasone ophthalmic insert 0.4 mg (Dextenza), produced by Ocular Therapeutix. It is the first FDA-approved, physician-administered intracanalicular insert, freeing patients from the need to apply eye drops by hand.
This most recent approval increases Dextenza’s approved uses to three. It means that the product can now be used to treat ocular itching from allergic conjunctivitis; the two other approved uses are for ocular pain after surgery and ocular inflammation after surgery.
The insert delivers a preservative-free preparation of the drug, thus lessening the risks of inflammation and damage to the tear film. One administration can last for up to 30 days; at the end of this period, the insert is resorbed and cleared via the nasolacrimal duct.
In a news release, Dr Michael Goldstein, president of ophthalmology and chief medical officer at Ocular Therapeutix, said: “We are really excited about this label expansion and the potential benefits for patients.” He continued, “The use of topical steroids is an important part of our current clinical armamentarium in the treatment of allergic conjunctivitis.”
Dr Goldstein observed that allergic conjunctivitis is a common condition. Previous studies have estimated that 10 millionindividuals in the US present each year with the complaint of inflammation associated with allergic conjunctivitis caused by seasonal and perennial allergens.1-3
Dr Steven Silverstein was an investigator in the Phase 3 trial of dexamethasone ophthalmic insert 0.4 mg.4 He stated, “Using skills that all ophthalmologists already possess, we now have the opportunity to remove the patient from drug administration, thus eliminating [nonadherence] as a potential cause of treatment failure.” He went on to say, “We found remarkable success in the reduction or elimination of the signs and symptoms of allergic conjunctivitis in the Phase 3 study during allergen challenge.”
Dexamethasone ophthalmic insert 0.4 mg (Dextenza, Ocular Therapeutix) was originally approved by the FDA in November 2018 to treat ocular pain after ophthalmic surgery. In June 2019, it was approved to treat ocular inflammation after ophthalmic surgery.
The latest approval of the drug to treat ocular itching associated with allergic conjunctivitis was based on the results of three randomised, multicentre, vehicle-controlled studies with a total of 255 participants.1-3 All participants had a positive history of ocular allergies and positive skin test reaction to perennial and seasonal allergens.
“In all three trials, Dextenza demonstrated lower mean ocular itching scores compared with the vehicle group at all time points throughout the study duration of up to 30 days,” the investigators said. “In two of the three studies, a higher proportion of patients had significant reductions in ocular itching on Day 8, at 3 minutes, 5 minutes and 7 minutes after the challenge in the Dextenza group compared [with] the vehicle group.”
The safety profile was also found to be favourable, and patients in all three studies tolerated the drug well.
When the data from the three studies were pooled, the most common ocular events were increased intraocular pressure (IOP) in 3% of participants, increased lacrimation and ocular discharge and reduced visual acuity, in 1% of participants each. Headache was the most common non-ocular adverse reaction to dexamethasone ophthalmic insert 0.4 mg, in 1% of the patient population treated for allergic conjunctivitis. The FDA approval was based on the results of a study published in the American Journal of Ophthalmology.5
Importantly, dexamethasone ophthalmic insert 0.4 mg is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, varicella; mycobacterial infections; fungal diseases of the eye; and dacryocystitis.