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 that there was a 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… When we talk to [contact lens wearers] 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.”

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 that this achievement required a strong collaboration between various teams and partners.

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. However, the lens can be worn for longer periods for vision correction.

Developing medication-releasing contact lenses has been a challenge for companies over the past 60 years. Pall explained the difficulties involved, such as finding compatibility between the medication and contact lens material and ensuring proper drug release.

Pall also discussed the potential of contact lenses in the future, stating, “The next breakthrough will be how can we continue to bring innovation to really help to enhance, to correct, and restore people’s vision.” He expressed excitement about being on the cutting edge of research and development to improve patients’ lives through contact lenses and other medical devices.

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