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 product’s popularity stems from its intuitive and logical design. Pall stated, “It all starts with the unmet need. Right now, 40% of contact lens wearers suffer from itchy-allergy-eyes. When we talk to them and ask them about when they have these itchy-allergy-eyes when wearing contact lenses about 80% say they’re frustrated. It really impacts their quality of life – the 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 emphasized the significant collaboration required to achieve this breakthrough, stating, “Something this breakthrough doesn’t happen…organically in just a small team of people. It’s a mass effort to make this happen.”
The FDA approval follows positive Phase 3 clinical studies published in the journal Cornea. These studies demonstrated a clinically and statistically meaningful reduction in itchy allergy eyes as quickly as three minutes after lens insertion, with effects lasting up to 12 hours. However, the lens 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 the difficulties involved, including finding compatibility between the medication and contact lens material and ensuring proper drug release.
While Pall did not discuss any specific projects, he highlighted the potential of contact lenses in the future. He expressed excitement about bringing innovation to enhance, correct, and restore people’s vision through contact lenses or other medical devices.