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 this product. He explained that the popularity of the lens is due to its intuitive and logical design, addressing the unmet need of 40% of contact lens wearers who experience itchy-allergy-eyes. Pall emphasized that this condition significantly impacts their quality of life.
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 teamwork involved in bringing 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, with many unsuccessful attempts. Pall discussed the difficulties involved in incorporating medication into the lens material and ensuring compatibility and release. Despite these challenges, he expressed optimism about the potential of contact lenses to enhance and restore vision in the future.
This FDA approval marks a significant milestone in improving the lives of contact lens wearers suffering from allergic eye itch. Johnson and Johnson’s Vision Care unit continues to innovate and develop solutions to enhance vision and improve patients’ quality of life.