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

Brian Pall, Director of Clinical Science at Johnson & Johnson Vision Care, expressed excitement about the product in an interview with MD+DI. He highlighted the high demand for the lens, stating that 40% of contact lens wearers currently experience itchy-allergy-eyes. Pall emphasized that this condition significantly 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 emphasized the importance of this collaboration and the collective effort required to bring about this breakthrough.

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. 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 unsuccessful attempts. Pall explained the difficulties involved in incorporating medication into the lens material and ensuring compatibility between the two. He also highlighted the importance of finding a balance where the drugs are compatible enough to be incorporated into the lens material but can still be released when placed on the eye.

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

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