FDA Approves Contact Lens With Antihistamine For Ocular Itch Prevention

US Food and Drug Administration

The US Food and Drug Administration (FDA) has approved the etafilcon A drug-eluting contact lens with ketotifen (ACUVUE® Theravision with Ketotifen) for the treatment of allergic eye itch in contact lens wearers.

The approval was granted to Johnson & Johnson Vision Care, Inc.

The novel technology combines the daily disposable contact lens with an antihistamine for the prevention of ocular itch due to allergic conjunctivitis and provide vision correction in patients who do not have red eyes, are suitable for contact lens wear, and who do not have more than 1.00 D of astigmatism. Each lens contains 19 micrograms of ketotifen, a well-established antihistamine.

"Ocular allergic itch in contact lens wearers may soon be an issue of the past thanks to the decision of the FDA in approving ACUVUE Theravision with Ketotifen," said Brian Pall, OD, MS, FAAO, Director, Clinical Science, Johnson & Johnson Vision Care in a statement. "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."

FDA’s approval has followed positive phase 3 clinical studies which determined the contact lens with ketotifen showed clinically and statistically meaningful reduction in itchy allergic eyes as quickly as 3 minutes after lens insertion and lasting up to 12 hours. The release noted the lens may be worn for longer than 12 hours for vision correction.

The company estimated that approximately 40% of contact lens wearers suffer from itchy eyes due to ocular allergies and nearly 8 out of 10 contact lens wearers with eye allergies agree that they are frustrated with allergies that interfere with their normal contact lens wear. Additionally, 1 in 2 contact lens wearers have said that the use of the drops are inconvenient.

"At Johnson & Johnson Vision, we are committed to bringing forward new technologies and innovations that can improve vision and overall eye health," said Thomas Swinnen, President, North America, Johnson & Johnson Vision Care, Inc in an accompanying statement. "This approval marks another significant milestone in Johnson & Johnson Vision's legacy of rethinking what's possible with contact lenses to meet the visual and eye health needs of people around the world."