The US Food and Drug Administration (FDA) has approved Johnson & Johnson Vision Care’s Acuvue Theravision with ketotifen, a drug-eluting contact lens to soothe allergic itchy eyes.
Each daily disposable lens contains 19μg ketotifen, a well-established antihistamine, making it the first in an entirely new category of contact lenses offering relief from ocular itch due to allergic conjunctivitis, said the company. They are suitable for patients who do not have red eyes, who are suitable for contact lens wear and who do not have more than 1.0D of astigmatism, reported JJ Vision Care.
The FDA approval follows positive phase 3 clinical studies, published by Cornea, demonstrating a clinically and statistically meaningful reduction in itchy allergy eyes three minutes after lens insertion and lasting up to 12 hours.
The lens has already received regulatory approval by the Japanese Ministry of Health and Health Canada, where patients already have access to the new lenses.
