FDA approves Johnson & Johnson's Acuvue Theravision with Ketotifen contact lens

The FDA has approved Acuvue Theravision with Ketotifen (etafilcon A drug-eluting contact lens with ketotifen), Johnson & Johnson Vision Care, Inc. announced Wednesday.

Acuvue Theravision with Ketotifen—an established antihistamine—is the first in a new category of contact lenses bringing a new experience for lens wearers with allergic eye itch. Each lens contains 19 mcg ketotifen.

The lenses are designed as daily disposable contact lenses intended for preventing ocular itch due to allergic conjunctivitis and providing vision correction in patients who do not have red eye, are suitable for contact lens wear, and who do not have astigmatism greater than 1.00 D, according to a news release.

“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,” said Brian Pall, OD, MS, FAAO, director, Clinical Sciences, Johnson and Johnson Vision Care, in a statement.

The news follows positive phase 3 clinical study results published in the Cornea and regulatory approval by the Japanese Ministry of Health, Labor and Welfare, and Health Canada, where the lenses are already accessible to patients, the company stated.

Per study results, Acuvue Theravision with Ketotifen exhibited a clinically and statistically meaningful reduction in itchy allergy in as fast as 3 minutes after lens insertion and lasted up to 12 hours.

However, results also showed the lens may be worn longer for vision correction.