May 20, 2022

New FDA-approved contact lens provides antihistamine for eye allergy relief

The first contact lens to deliver a drug directly to the surface of the eye was approved this week by the US Food and Drug Administration (FDA) to relieve symptoms of eye allergy.

The green light for Johnson & Johnson’s Acuvue Theravision With Ketotifen, a soft disposable lens infused with an ophthalmic antihistamine, opens the door to a new class of eye treatments. Already available in Japan and Canada, the lens is designed to release the drug and relieve itching, redness and burning caused by allergies within minutes of insertion into the eye.

Symptoms can be eliminated for up to 12 hours, according to Johnson & Johnson. The lenses can continue to be worn for vision correction after the drug wears off, the drug company said.

Intended for contact wearers with eye allergies

The product solves a problem that potentially affects millions of people who find contact lenses uncomfortable or impossible to wear in the presence of allergens such as pollen, ragweed and animal dander. Johnson & Johnson markets the contacts as a medication delivery system that helps the many people with itchy eyes due to allergies who find eye drops inconvenient or difficult to use. Because sterile lenses are replaced daily, they also eliminate the risk of contamination from mishandling eye drops.

“Another potential benefit is that the drug used is preservative-free,” says Stephen Pflugfelder, MD, professor and James and Margaret Elkins Chair in Ophthalmology at Baylor College of Medicine in Houston.

The federal Centers for Disease Control and Prevention (CDC) in Atlanta estimates that more than 40 million American adults wear contacts, 93% of whom opt for the soft type.

“We know that 40% of contact lens wearers suffer from eye allergies, and when you ask them how it affects their quality of life, 8 out of 10 told us that they find it very frustrating not to be able to wear the lenses. in certain situations,” says Brian Pall, OD, director of clinical sciences at Johnson & Johnson Vision in Jacksonville, Florida.

Drug-eluting contact lenses, a long-awaited goal

Dr. Pall served as the head of clinical research for the Acuvue Theravision With Ketotifen project, testing a variety of materials and drugs before finding the right combination to make the imagined concept a reality.

“The idea of ​​incorporating drugs into a lens has been discussed for over 60 years,” Pall says. “But the breakthrough came when we were able to choose one of our Acuvue materials.” These materials, he explained, have a long track record, as does the drug used in lenses.

Ketotifen, a key ingredient in many eye drops, is available over the counter and by prescription. It prevents mast cells (mobilized when the body perceives an attack) from releasing substances that cause allergy symptoms. The drug is also used to treat asthma and systemic allergies.

Cost of lenses not yet established

Acuvue Theravision With Ketotifen has not yet been priced, the manufacturer says. For comparison, Ketotifen Fumarate Ophthalmic Solution 0.025% can be found for around $20 for 5 milliliters – a 30 day supply.

“While allergy sufferers who wear contact lenses would find it more convenient than a drop, you need to consider the cost-benefit of contact lenses,” says Dr. Pflugfelder.

Minor and temporary side effects

The only side effect reported to date is temporary discomfort when inserting the contacts.

“The most common side effect was observed in less than 2% of subjects in the clinical trial, and it was a mild tingling or stinging at the time of contact insertion, meaning that 98 % of clinical trial subjects reported no irritation,” Voile said.

The lenses are not compatible with existing soft lens cleaning solutions and are intended for disposal after one wear. Johnson & Johnson warns that lenses, as daily disposables, should not be left in the eye overnight.