May 20, 2022

FDA approves disposable contacts with antihistamine for allergic conjunctivitis

The Food and Drug Administration (FDA) has approved Acuvue® Theravision™ with Ketotifen (Etafilcon A with Ketotifen drug-eluting contact lens) for the prevention of itchy eyes due to allergic conjunctivitis and the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or phakic patients who do not have red eyes), are suitable for wearing contact lenses and have no more than 1 D of astigmatism.

The approval was based on data from 2 randomized, placebo-controlled Phase 3 conjunctival allergen challenge clinical studies (ClinicalTrials.gov identifier: NCT00445874, NCT00432757), which compared the efficacy and safety of Acuvue Theravision with Ketotifen to a placebo (1•DAY Acuvue®) in patients with allergic conjunctivitis.

The results of both studies demonstrated that Acuvue Theravision with Ketotifen was safe and more effective in preventing itchy eyes compared to placebo. Acuvue Theravision with Ketotifen reduced eye itching within 3 minutes and response was maintained for up to 12 hours after lens insertion. Visual acuity was found to be comparable between the two 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 commonly reported adverse reactions during use included eye irritation, eye pain and pain at the instillation site.

Acuvue Theravision with Ketotifen can be inserted per eye per day and should be discarded after only one day of use. Each lens contains 19 mcg of ketotifen. Itch prevention has been shown to last for 12 hours; however, the lens can be worn for more than 12 hours in a single day. Contact lens cleaning and disinfecting solutions should not be used with this product.

The references

  1. Johnson & Johnson Vision Care receives FDA approval for Acuvue® Theravision™ with Ketotifen – the world’s first and only drug-eluting contact lens. Press 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.
  2. Acuvue® Theravision™ with ketotifen. Packing note. 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.