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 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 product’s popularity stems from its intuitive and logical design. Currently, 40% of contact lens wearers suffer from itchy-allergy-eyes, and about 80% of them feel frustrated by 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 various partners involved in the development of this breakthrough product.
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 failed attempts. Pall explained the difficulties involved in incorporating medication into the lens material and ensuring compatibility and proper drug release.
While Pall did not discuss any specific projects, he expressed excitement about the potential of contact lenses in the future. He emphasized the importance of bringing innovation to enhance and restore people’s vision, highlighting the role of contact lenses and other medical devices in improving patients’ lives.
Overall, Johnson and Johnson’s FDA approval for its drug-eluting contact lens represents a significant advancement in the field and offers hope for contact lens wearers suffering from allergic eye itch.