Johnson & Johnson Vision has unveiled new Phase 3 data from two clinical studies of its antihistamine-releasing contact lenses, showing that they were able to reduce itchy sensations in the eyes after exposure to allergens.
The soft disposable lenses are made from Etafilcon A, the material used for most J&J Acuvue daily wear lenses, and have been combined with a small amount of antihistamine ketotifen, the active ingredient in Zaditor anti-allergy eye drops. Alcon.
Both trials randomized participants into one of three arms: one who received a pair of anti-drug lenses, one as a control group with regular lenses, and a group who received one of each in each eye.
Although antihistamine-eluting lenses did not demonstrate a clinically significant reduction in eye redness, the secondary endpoint of the trials, mean itch scores were significantly lower in the experimental groups.
“These Phase 3 study results are important on several fronts,” J&J Vision Director of Clinical Sciences Brian Pall said in a statement. declaration. “There was both clinically and statistically significant reduction in itchy eyes which occurred 15 minutes after lens insertion and lasted for the 12 hour study evaluation period.”
“This is the first time that contact lens technology has shown its potential in a large-scale study to treat itching due to eye allergies,” added Pall, who was the lead author of the trials manuscript, published in the journal Cornea.
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J&J estimates that one in five people in the United States, and worldwide, suffer from an allergic reaction with itching in the eyes when exposed to irritants such as tree or grass pollen. , animal dander or dust.
“It is encouraging to see this large-scale evaluation which indicates the potential of a contact lens drug delivery system which, in the future, could represent a whole new category of contact lenses,” said said Xiao-Yu Song, Global Head of J&J Vision. R&D manager. “We will continue to develop this contact lens technology and are committed to submitting regulatory submissions for this contact lens releasing antihistamines as we move forward. “