The daily disposable contact lenses are intended to prevent ocular itching due to allergic conjunctivitis
ACUVUE Theravision with Ketotifen are daily wear, daily disposable drug-eluting contact lenses. (Credit: LhcCoutinho from Pixabay)
Johnson & Johnson (J&J) Vision Care announced that US Food and Drug Administration (FDA) has approved its ACUVUE Theravision with Ketotifen.
ACUVUE Theravision with Ketotifen are daily wear, daily disposable drug-eluting contact lenses, with each lens consisting of 19mcg ketotifen, which is a popular antihistamine.
The firm claims that the new contact lens with ketotifen are designed for vision correction in patients without red eyes and who do not have more than 1.00 D of astigmatism.
Johnson & Johnson Vision Care North American president Thomas Swinnen 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.”
J&J stated that ACUVUE Theravision with Ketotifen is world’s first and only drug-eluting daily disposable contact lens that will provide new experience of wearing lens with allergic eye itch.
The FDA approval comes after Phase 3 clinical studies published in the journal Cornea and regulatory approval by the Japanese Ministry of Health, Labor and Welfare, and Health Canada.
The phase 3 study showed reduction in itchiness quickly after 3 minutes of lens insertion and lasting up to 12 hours.
According to the company, lens may be worn for more than 12 hours for vision correction.
Johnson & Johnson Vision Care clinical science director Brian Pall said: “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.
“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.”