The Food and Drug Administration (FDA) has approved Acuvue® Theravision™ with Ketotifen (etafilcon A drug-eluting contact lens with ketotifen) for the prevention of ocular itch due to allergic conjunctivitis and correction of refractive ametropia (myopia and hyperopia) in aphakic and/or phakic patients who do not have red eye(s), are suitable for contact lens wear and do not have more than 1 D of astigmatism.
The approval was based on data from 2 randomized, placebo-controlled clinical conjunctival allergen challenge phase 3 studies (ClinicalTrials.gov Identifier: NCT00445874, NCT00432757), which compared the efficacy and safety of Acuvue Theravision with Ketotifen to placebo (1•DAY Acuvue®) in patients with allergic conjunctivitis.
Findings from both studies demonstrated that Acuvue Theravision with Ketotifen was safe and more effective for the prevention of ocular itching compared with placebo. Acuvue Theravision with Ketotifen reduced ocular itching within 3 minutes and the response was sustained for up to 12 hours after lens insertion. Visual acuity was found to be comparable between both groups. The application also included data from two 12-week safety studies (ClinicalTrials.gov Identifier: NCT00889252, NCT00569777).
Acuvue Theravision with Ketotifen is contraindicated in patients with ocular hyperemia, corneal hypoesthesia, or corneal infections. The most common adverse reactions reported with use included eye irritation, eye pain, and instillation site pain.
Acuvue Theravision with Ketotifen may be inserted per eye per day and should be discarded after a single day’s use. Each lens contains 19 mcg of ketotifen. The prevention of itch has been demonstrated to last through 12 hours; however, the lens may be worn for longer than 12 hours in a single day. Contact lens cleaning and disinfectant solutions should not be used with this product.
- Johnson & Johnson Vision Care receives FDA approval for Acuvue® Theravision™ with Ketotifen – world’s first and only drug-eluting contact lens. News release. Johnson & Johnson Vision Care, Inc. March 2, 2022. Accessed March 4, 2022. https://www.jjvision.com/press-release/johnson-johnson-vision-care-receives-fda-approval-acuvuer-theravisiontm-ketotifen.
- Acuvue® Theravision™ with Ketotifen. Package insert. Johnson & Johnson Vision Care, Inc.; 2022. Accessed March 4, 2022. https://image.s7.sfmc-content.com/lib/fe9413727c67047d73/m/1/ba6d02b0-d2d2-473e-bc0e-ebcc2482cf7d.pdf?utm_medium=email&utm_source=ACUVUE%c2%ae+Theravision%e2%84%a2+Professional+Lead+Gen+Confirmation+Email&utm_campaign=&src=7293006.