JACKSONVILLE, FL — Johnson & Johnson Vision Care Inc. announced that the U.S. Food and Drug Administration has approved Acuvue Theravision with Ketotifen.
Each lens contains 19 mcg of ketotifen, an established antihistamine. Acuvue Theravision with Ketotifen “is the first in an entirely new category of contact lenses and brings forward a new wearing experience for contact lens wearers with allergic eye itch,” according to a press release from J&J Vision.
J&J Vision described the product as “the world’s first and only drug-eluting contact lens.”
The product (etafilcon A drug-eluting contact lens with ketotifen) consists of daily disposable contact lenses indicated to prevent ocular itch due to allergic conjunctivitis and provide vision correction in patients who do not have red eyes, who are suitable for contact lens wear and who do not have more than 1.00 D of astigmatism.
The announcement follows positive Phase 3 clinical studies published in the journal Cornea and regulatory approval by the Japanese Ministry of Health, Labor and Welfare, and Health Canada, where patients already have access to the lenses. According to the Phase 3 clinical studies, Acuvue Theravision with Ketotifen showed a clinically and statistically meaningful reduction in itchy allergy eyes as quickly as 3 minutes after lens insertion and lasting up to 12 hours,” according to the release. The lens may be worn for longer than 12 hours for vision correction.
“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 Dr. Brian Pall, director, clinical science, for J&J Vision Care. “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.”
Thomas Swinnen, president, North America, for J&J Vision Care, said, “At Johnson & Johnson Vision, we are committed to bringing forward new technologies and innovations that can improve vision and overall eye health. 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.”