First Drug-Eluting Contact Lens Wins FDA Nod

A drug-eluting contact lens containing an antihistamine for people with allergic eye itch won approval from the FDA, Johnson & Johnson Vision Care announced.

The daily disposable etafilcon A drug-eluting contact lens with ketotifen (Acuvue Theravision with ketotifen) is the world’s first drug-eluting contact lens, the company said. It recently was approved in Japan and Canada as well.

“These new lenses may help keep more people in contact lenses, since they relieve allergic eye itch for up to 12 hours, without the need for allergy drops, and provide vision correction,” Brian Pall, OD, MS, director of clinical science at Johnson & Johnson Vision Care, said in a statement.

Each lens contains 19 mcg of ketotifen, an antihistamine commonly found in allergy eye drops. Eye drops are a very common treatment for itchy eyes, but one in two contact lens wearers say drops are inconvenient to use, according to a Johnson & Johnson survey.

The drug-eluting contact lens is indicated to prevent ocular itch from allergic conjunctivitis while also correcting refractive error (myopia or hyperopia) in both aphakic and phakic patients (patients with or without lens implants). The daily lens can be used in patients who do not have red eyes, can wear contacts, and do not have more than 1.00 D of astigmatism.

FDA approval for the novel contact lens comes after two phase III trials, which found that patients age 8 and older who wore them had both a clinically and statistically significant reduction in their eye itch at 15 minutes and up to 12 hours, though the lens can be worn for more than 12 hours a day for vision correction.

“Combining vision correction and therapeutic treatment for allergy increases compliance for both conditions by simplifying overall management,” the investigators wrote in Cornea. There was no evidence from either study that incorporating the drug into the lens solution had any structural, optical, or refractive effect on the lenses, they noted.

The most commonly observed adverse reactions in the trials were eye irritation, eye pain, and instillation site pain, according to the FDA label. The drug-eluting contact lens should not be used in patients with ocular hyperemia, corneal hypoesthesia, or corneal infections, the label also noted.