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 almost a year after the product was 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 that there is a high demand for this product due to its intuitive and logical design. Pall explained that currently, 40% of contact lens wearers experience itchy-allergy-eyes, and 80% of them feel frustrated by this issue, which significantly impacts their quality of life.

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 was the result of a strong collaboration between J&J Vision Care, Janssen, and other strategic 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, lasting up to 12 hours. However, the lenses can be worn for longer periods for vision correction.

Developing medication-releasing contact lenses has been a challenge for companies over the past 60 years. Pall highlighted the difficulties in incorporating medication into the lens material and ensuring compatibility between the drug and contact lens material. He also mentioned the importance of finding a balance between compatibility and drug release.

Pall also discussed the potential of contact lenses in the future, emphasizing the goal of enhancing, correcting, and restoring people’s vision. He expressed excitement about being on the cutting edge of research and development to improve patients’ lives through contact lenses and other medical devices.

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