Johnson & Johnson Vision announced today that it received FDA approval for its Acuvue Theravision with Ketotifen.
The eye health business arm of Johnson & Johnson (NYSE: JNJ) designed Acuvue Theravision with ketotifen (etafilcon A drug-eluting contact lens with ketotifen) to provide a new wearing experience for contact lens wearers who have allergic eye itch for up to 12 hours without the need for allergy drops while also providing vision correction.
According to a news release, Acuvue Theravision with Ketotifen lenses are daily disposable contacts indicated for the prevention of ocular itch due to allergic conjunctivitis. They 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.
Health Canada approved the drug-eluting contact lens in April 2021, just one month after the product received regulatory approval in Japan.
FDA approval follows positive Phase 3 clinical studies in which Acuvue Theravision with Ketotifen showed a clinically and statistically meaningful reduction in itchy allergy eyes as quickly as three minutes after lens insertion and lasting up to 12 hours. The lens may be worn for longer than 12 hours for vision correction purposes.
“At Johnson & Johnson Vision, we are committed to bringing forward new technologies and innovations that can improve vision and overall eye health,” Johnson & Johnson Vision North America President Thomas Swinnen said in the release. “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.”