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 after the product was previously 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 this product. He explained that many contact lens wearers experience itchy-allergy-eyes, which significantly impacts their quality of life. The Acuvue Theravision with Ketotifen aims to address this unmet need.
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 extensive collaboration required to bring this breakthrough product to market.
Positive Phase 3 clinical studies published in the journal Cornea further support the efficacy of the drug-eluting lens. 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. It is important to note that the lens can be worn for longer than 12 hours for vision correction purposes.
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 proper drug release.
While Pall did not discuss any specific projects, he expressed enthusiasm for the potential of contact lenses in the future. He emphasized the importance of innovation in enhancing and restoring people’s vision, highlighting the role of contact lenses and other medical devices in improving patients’ lives.
The FDA approval of Johnson and Johnson’s Acuvue Theravision with Ketotifen marks a significant milestone in the field of contact lens technology and offers hope for contact lens wearers suffering from allergic eye itch.