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 in contact lens wearers suffering from 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 40% of contact lens wearers currently experience itchy-allergy-eyes, and about 80% of them feel frustrated by this issue. Pall emphasized the impact on their quality of life and 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 within three minutes of 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 purposes.
Developing medication-releasing contact lenses has been a challenge for companies over the past 60 years, with many unsuccessful attempts. Pall explained the difficulties involved in incorporating medication into the lens material and ensuring compatibility between the drug and contact lens material. The release of the drug from the lens material is also a crucial factor that needs to be addressed.
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, correct, and restore people’s vision, and how this motivates him as an R&D professional.
Overall, Johnson and Johnson’s FDA approval for its drug-eluting contact lens brings hope to contact lens wearers suffering from allergic eye itch. The company’s collaboration and dedication to finding solutions for patients’ needs are evident in this breakthrough product.