Johnson and Johnson’s Vision Care unit has received FDA approval for its Acuvue Theravision with Ketotifen, a drug-eluting contact lens that could potentially eliminate the need for eyedrops for contact lens wearers with 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 many contact lens wearers suffer from itchy-allergy-eyes, which greatly impacts their quality of life. Pall emphasized that the Acuvue Theravision with Ketotifen is intuitive and logical, making it a popular choice among consumers.
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 extensive collaboration required to bring this breakthrough product to market.
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. Pall explained that incorporating medication into the lens requires compatibility between the drug and contact lens material. Additionally, the drug must be released effectively once the lens is placed on the eye.
Pall also mentioned the potential of contact lenses in the future, emphasizing the goal of enhancing and restoring people’s vision. He expressed excitement about being on the cutting edge of research and development, seeking innovative solutions to improve patients’ lives through contact lenses and other medical devices.