The United States Food and Drug Administration has approved a new contact lens that elutes the antihistamine ketotifen as a treatment for eye allergy.
“This is the world’s first and only contact lens capable of preventing itching associated with allergies, while providing vision correction,” said Brian Pall, DO, director of clinical sciences at Johnson & Johnson Vision Care, which makes the lens. “It’s certainly exciting.”
The new lens, Acuvue Theravision With Ketotifenis, is already on the market in Canada and Japan.
The lenses are daily disposable contacts indicated for the prevention of itchy eyes due to allergic conjunctivitis in persons who do not have red eyes, are suitable for wearing contact lenses and have no more than 1.00 D of astigmatism.
Antihistamine eye drops are contraindicated for use with contact lenses because eye drop preservatives can interact with the lenses, and clinical trials generally exclude contact lens wearers.
Johnson & Johnson worked for more than a decade to find an antihistamine that pairs well with contact lens material, eventually finding the combination of ketotifen and etafilcon A, Pall said. The drug is embedded in the polymer during manufacturing.
On contact with the eye, the drug diffuses from the lens into the tear film and is absorbed by the ocular tissues, much like conventional eye drops. “The main difference is that it’s a slower version,” Pall said. “Instead of a bolus of this big drop that hits the eye and then is immediately expelled, we get a much more sustained release.”
Since the lens is kept sterilized until use, no preservatives are added to the medicine. This is an advantage because preservatives cause irritation in some patients.
Ketotifen, a well-established treatment for eye allergies, not only blocks histamine receptors, but also stabilizes mast cells so that they do not release cytokines, and it prevents inflammatory cells from rushing to the site of irritation, said Pall.
For a pair of identical clinical trials, published in 2019 in Cornea , Pall and his colleagues recruited 244 people with eye allergies. For each trial, they divided these subjects into three groups. One group wore ketotifen lenses in one eye and drug-free lenses in the other eye. The second group wore the ketotifen lenses in both eyes. The third wore control lenses in both eyes.
The researchers then exposed the subjects to allergens and asked them to rate how itchy their eyes were on a scale of 0 to 4 after 3 minutes, 5 minutes and 7 minutes. During these periods, patients rated itchy eyes with ketotifen contact lenses as an average of 0.42 to 0.59; they rated the eyes with the control contacts from 1.60 to 1.94. The differences were statistically significant (P
While approximately 5% of patients experienced adverse events, most events were not judged to be contact lens related. The most common adverse event, reported by approximately 1% of patients, was irritation of the site of installation. “The good news, what we’re hearing in the field, is that it’s very subtle, it’s quite mild and it dissipates quickly,” Pall said.
The new contact lens “holds promise for contact lens wearers and the 20 to 40 percent of the U.S. population who suffer from allergies,” said Leonard Bielory, MD, professor of medicine, allergy, immunology and ophthalmology at the Hackensack Meridian School. of Medicine in Nutley, New Jersey, which was not involved in the testing or development of the lens.
“I have patients who wear contacts and have allergies, and they have to work around that,” he said. Medscape Medical News. “I expected this 15 years ago, because it’s a good idea.”
Johnson & Johnson is studying other drugs that could be delivered through contact lenses, Pall said.
The study was funded by Johnson and Johnson. Pall is an employee of Johnson & Johnson. Bielory does not report any relevant financial relationship.
Laird Harrison writes about science, health and culture. His work has appeared in magazines, newspapers, on public radio and on websites. He is working on a novel about alternate realities in physics. Harrison teaches writing at Writers Grotto. Visit him at lairdharrison.com or follow him on Twitter: @LairdH.
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