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 lens stems from its intuitive and logical design, addressing the unmet need of the 40% of contact lens wearers who suffer from itchy-allergy-eyes. Pall emphasized that this condition significantly impacts their quality of life.

Each lens contains 19 mcg of ketotifen, a well-established antihistamine, and was developed through a collaboration between J&J Vision Care and Janssen, a subsidiary of J&J. Pall highlighted the extensive teamwork required to achieve this breakthrough.

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 that incorporating medication into the lens requires compatibility between the drug and contact lens material. Additionally, the drug must be released from the lens when placed on the eye.

Pall also expressed excitement about the future potential of contact lenses. While not referring to any specific projects, he emphasized the importance of innovation in enhancing and restoring people’s vision through contact lenses and other medical devices.

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