Johnson & Johnson Vision Receives FDA Approval for First Drug-Eluting Contact Lens—Acuvue Theravision with Ketotifen

Johnson & Johnson Vision Care announced that the FDA has approved Acuvue Theravision with Ketotifen (etafilcon A drug-eluting contact lens with ketotifen), the first drug-eluting contact lens. Each lens contains 19 mcg ketotifen, an antihistamine. 

Acuvue Theravision with Ketotifen are daily disposable contact lenses indicated for the prevention of 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. 

Today’s 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 new 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; however, 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,” Brian Pall, OD, MS, FAAO, Director, Clinical Science, Johnson & Johnson Vision Care, said in a company news release. “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.”

For more information, visit: www.acuvuetheravision.com. For full Prescribing Information, click here and to view the Patient Instruction Guide click here.