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 the high demand for the product. He explained that the popularity of the drug-eluting lens stems from its intuitive and logical design. Currently, 40% of contact lens wearers experience itchy-allergy-eyes, and about 80% of them express frustration. 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 strong collaboration between J&J Vision Care, Janssen, and other strategic partners, emphasizing that such breakthroughs require a collective effort.
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 discussed the difficulties involved in incorporating medication into the lens material and ensuring compatibility and elution. Despite not referring to a specific project, he expressed excitement about the potential of contact lenses to enhance and restore people’s vision in the future.
Overall, Johnson and Johnson’s FDA approval for its drug-eluting contact lens offers hope for contact lens wearers suffering from allergic eye itch, providing a convenient alternative to traditional eyedrops.