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. The approval comes after the product was already approved for use by the Japanese Ministry of Health last year.

Brian Pall, Director of Clinical Science at Johnson & Johnson Vision Care, explained in an interview that there has been a high demand for the product due to its intuitive and logical design. He highlighted the unmet need among contact lens wearers, with 40% experiencing itchy-allergy-eyes. Pall emphasized that this condition greatly impacts their quality of life and limits their ability to do the things they want to do.

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 praised the strong collaboration between the different teams involved in developing this breakthrough product.

The FDA approval follows positive Phase 3 clinical studies published in the journal Cornea. These studies demonstrated a significant reduction in itchy allergy eyes as quickly as three minutes after lens insertion, with effects 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 explained that incorporating medication into the lens requires compatibility between the drug and contact lens material. Additionally, the drug must be released from the lens when placed on the eye.

Pall also expressed his excitement about the future potential of contact lenses, emphasizing the goal of enhancing, correcting, and restoring people’s vision. He highlighted the importance of innovation in improving patients’ lives through contact lenses and other medical devices.

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