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 popularity of the product 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 importance of this collaboration, stating, “This was a great example of a very strong collaboration between J&J Vision Care, Janssen, and other strategic partners that we’ve worked with. 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 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 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 explained the difficulties involved in the process, including finding compatibility between the medication and contact lens material and ensuring proper drug release.

Pall also highlighted 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. That’s what gets me excited to be an R&D person – to be able to be on that cutting edge and really look for these difficult challenges on how to make patients’ lives better through contact lenses or other medical devices.”

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