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 in 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 40% of contact lens wearers currently experience itchy-allergy-eyes, and about 80% of them feel frustrated by this issue. 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 highlighted the importance of this collaboration and the collective effort required to achieve such a 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. However, the lens 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, with many unsuccessful attempts. Pall explained the difficulties involved 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 where the drugs are compatible enough to be seamlessly incorporated into the material but can still be released when placed on the eye.

Pall also discussed the future potential of contact lenses, expressing excitement about bringing innovation to enhance and restore people’s vision. He emphasized the role of research and development in addressing challenging issues and improving patients’ lives through contact lenses and other medical devices.

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