FDA Approves J&J Vision’s ACUVUE Theravision Drug-Eluting Contact Lenses

Johnson & Johnson Vision Care has received U.S. Food and Drug Administration (FDA) approval for its ACUVUE Theravision with Ketotifen (etafilcon A drug-eluting contact lens with ketotifen). Each lens contains 19 micrograms of ketotifen, a well-established antihistamine, to help lens wearers suffering from allergic eye itch.
 
The daily disposable contact lenses are indicated to prevent ocular itch from allergic conjunctivitis and correct vision for those without red eyes suitable for lens wear and without over 1.00 D of astigmatism.
 
According to J&J Vision data on file, about 40 percent of contact lens wearer suffer from itchy eyes due to ocular allergies. Almost 8 out of 10 wearers with eye allergies also express frustration when allergies interfere with normal wear.
 
The approval was supported by Phase 3 clinical studies published in Cornea and regulatory approval from the Japanese Ministry of Health, Labor and Welfare as well as Health Canada. The studies showed meaningful itchy allergy eye reduction as fast as three minutes after lens insertion and lasting up to 12 hours.
 
“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 told the press. “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.”
 
“At Johnson & Johnson Vision, we are committed to bringing forward new technologies and innovations that can improve vision and overall eye health,” said Thomas Swinnen, President, North America, Johnson & Johnson Vision Care. “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.”