Last week, the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson Vision Care’s drug-eluting contact lens loaded with the antihistamine drug Ketotifen to treat common allergic eye itch in contact wearers, according to MedCity News.
The disposable contact lens, called Acuvue Theravision with Ketotifen, delivers Ketotifen for ocular itch while also correcting refractive errors.
Ketotifen is used to prevent and treat itching of the eyes caused by allergies (allergic or seasonal conjunctivitis), according to WebMD. It is an antihistamine and mast cell stabilizer. The drug, which comes in an ophthalmic solution, is available as an over-the-counter product.
According to the company’s news release, about 40% of contact lens users report allergy-induced itchy eyes. The newly approved J&J contact lenses can relieve itchy eyes in under 3 minutes and can treat itchy eyes for up to 12 hours. Plus, the lenses can be worn for a longer duration to correct vision.
This FDA approved the product after considering the results of Phase 3 clinical trials.
J&J claimed that Acuvue Theravision with Ketotifen is a novel contact lens altogether because it corrects vision as well as provides allergy relief.
Brian Pall, Director, Global Clinical Science, J&J Vision Care, said in an email interview, “Acuvue Theravision with Ketotifen is the world’s first and only drug-eluting contact lens for the relief of itchy allergy eyes due to common seasonal allergens such as tree or grass pollen, and other perennial allergens like pet dander or household dust.”
“Companies have spent 60 years trying to develop medication-releasing contact lenses,” he explained.
“The idea of drug-releasing contact lenses was recorded in some of the original soft contact lens patents from the early 1960’s. Since that time, hundreds of manuscripts have been published from academic and independent researchers that document their attempts to incorporate medications into contact lenses,” Pall added. “Until now, no one has been able to successfully develop and commercialize a drug-eluting contact lens.”
Acuvue Theravision with Ketotifen will be available under a doctor’s prescription. The company did not comment on the price of the product in the U.S. market as of yet.
Pall said, “Johnson & Johnson Vision Care scientists worked for over a decade to find the right combination of medication and lens material, infuse the medication without compromising vision and to achieve a combination that is safe and clinically proven efficacious.”
“This FDA approval marks another significant milestone in Johnson & Johnson Vision’s legacy of rethinking what’s possible with contact lenses and bringing forward innovations to better meet the visual and eye health needs of people around the world,” he added. The story was first published in MedCity News.
