Johnson and Johnson’s Vision Care unit has received FDA approval for its Acuvue Theravision with Ketotifen, a drug-eluting contact lens that could eliminate the need for eyedrops for contact lens wearers suffering from allergic eye itch. This approval comes after the product was previously approved for use by the Japanese Ministry of Health.

In an interview with MD+DI, Brian Pall, Director of Clinical Science at Johnson & Johnson Vision Care, expressed the high demand for the product. He explained that many contact lens wearers experience itchy-allergy-eyes, which greatly impacts their quality of life. The Acuvue Theravision with Ketotifen aims to address this unmet need.

Each lens contains 19 mcg of ketotifen, a well-established antihistamine. The vision care unit collaborated with J&J’s Janssen for the antihistamine component. Pall emphasized that this breakthrough required a strong collaboration between various partners.

The FDA approval follows positive Phase 3 clinical studies published in the journal Cornea. These studies demonstrated a significant reduction in itchy allergy eyes within three minutes of lens insertion, with effects lasting up to 12 hours. It should be noted that the lens can be worn for longer than 12 hours for vision correction purposes.

Developing medication-releasing contact lenses has been a challenge for companies over the past 60 years, with many attempts failing. Pall explained the difficulties involved in incorporating medication into the lens material and ensuring compatibility. However, he remains optimistic about the future potential of contact lenses in enhancing and restoring people’s vision.

Overall, Johnson and Johnson’s FDA approval for the Acuvue Theravision with Ketotifen offers hope for contact lens wearers suffering from allergic eye itch. The innovative drug-eluting lens could provide a convenient and effective solution to improve their quality of life.

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