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 lens 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 was 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. The impact on their quality of life is significant, affecting their ability to do the things they want to do.
Each lens contains 19 mcg of ketotifen, a well-established antihistamine. Johnson and Johnson’s 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 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 as quickly as three minutes after lens insertion, with effects lasting up to 12 hours. It is important to note that the lens can be worn for longer than 12 hours 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 that the process is difficult due to the need for compatibility between the medication and contact lens material, as well as ensuring proper release of the drug.
Pall also highlighted the potential of contact lenses in the future, stating that the next breakthrough will focus on enhancing and restoring people’s vision. He expressed excitement about being on the cutting edge of research and development, seeking ways to improve patients’ lives through contact lenses and other medical devices.