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 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 drug-eluting lens is due to its intuitive and logical design. Currently, 40% of contact lens wearers experience itchy-allergy-eyes, and approximately 80% of them express frustration with this issue, which significantly 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 the importance of this collaboration and described it as a mass effort 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 lenses 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, with many unsuccessful attempts. Pall explained the difficulties involved in incorporating medication into the lens material and ensuring compatibility and release. Despite these challenges, he expressed optimism about the potential of contact lenses in the future to enhance and restore people’s vision.
Overall, Johnson and Johnson’s FDA approval for its drug-eluting contact lens represents a significant advancement in providing relief for contact lens wearers suffering from allergic eye itch.