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 with 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 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. It is important to note that the lenses 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 acknowledged the difficulties involved in this process, particularly in finding the right synergy and compatibility between the medication and contact lens material. Additionally, ensuring that the drug is released from the lens material once placed on the eye presents another challenge.
Pall also discussed the potential of contact lenses in the future, emphasizing the company’s commitment to enhancing, correcting, and restoring people’s vision. He expressed excitement about being on the cutting edge of research and development, seeking solutions to improve patients’ lives through contact lenses and other medical devices.