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 eye drops for contact lens wearers suffering from allergic eye itch. The lens, which goes beyond the limits of traditional eyewear, contains 19 mcg of ketotifen, a well-established antihistamine. This breakthrough 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 excitement about the product, stating that there was a high demand for it due to its intuitive and logical design. Pall emphasized the unmet need for a solution to itchy-allergy-eyes among contact lens wearers, with 40% of them currently experiencing this issue. He noted that the condition significantly impacts their quality of life and limits their ability to do the things they want to do.
The development of medication-releasing contact lenses has been a challenge for companies over the past 60 years, with many failed attempts. Pall explained that one of the main challenges is finding compatibility between the medication and contact lens material. Additionally, ensuring that the drug is released from the lens when placed on the eye is another hurdle. However, Johnson and Johnson’s collaboration with Janssen and other strategic partners has led to 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 is important to note that the lens can be worn for longer than 12 hours for vision correction.
Pall also highlighted the potential of contact lenses in the future, stating that the next breakthrough would be focused on enhancing, correcting, and restoring people’s vision. He expressed enthusiasm for being on the cutting edge of research and development, searching for innovative solutions to improve patients’ lives through contact lenses and other medical devices.