J&J’s antihistamine-eluting contact lenses clear phase 3 allergy studies

J&J said it is committed to making regulatory submissions and will continue to develop what it says could become an entirely new category of contact lenses. (Unsplash)

Johnson & Johnson Vision has unveiled new phase 3 data from two clinical studies of its antihistamine-releasing contact lens, showing that it was able to reduce feelings of itchy eyes after exposure to allergens.

The soft, disposable contacts are made of etafilcon A—the material used for many of J&J’s Acuvue daily-wear lenses—and were combined with a small amount of the antihistamine ketotifen, the active ingredient in Alcon’s Zaditor anti-allergy eyedrops.

Both trials randomized participants to one of three arms: one that received a pair of the drug-releasing lenses, one as a control group with regular lenses, and one group that received one of each in each eye.

WEBINAR

Webinar: Meet the Challenge of Complex Protein Expression

As market demand continues to rise for more potent and effective therapeutics, biologic pipelines are evolving from standard antibody formats to next-generation biologics (NGBs). In this webinar we will discuss and demonstrate application through case studies, two significant enhancements to Lonza’s GS Xceed® expression system to help address the challenges of NGBs.

While the antihistamine-eluting lenses did not demonstrate clinically significant reductions in eye redness, the trials’ secondary endpoint, average itching scores were significantly lower across the investigational groups.

"These phase 3 study results are important on multiple fronts,” J&J Vision’s director of clinical science, Brian Pall, said in a statement. "There was both a clinically and statistically significant reduction in ocular itching that occurred 15 minutes after lens insertion and lasted for the 12-hour study evaluation period.”

“This marks the first time that contact lens technology has shown potential in a large-scale study to address itch stemming from ocular allergies,” added Pall, who served as lead author of the trials’ manuscript, published in the journal Cornea.

RELATED: Drug-delivering contact lens reduces eye pressure in glaucoma

J&J estimates that 1 in 5 people in the U.S., and similarly worldwide, experience an itchy allergic reaction in the eyes when exposed to irritants such as tree or grass pollen, pet dander or dust.

“It is encouraging to see this large-scale assessment that indicates the potential of a contact lens-based drug delivery system which, in the future, could represent an entirely new category of contact lenses,” said Xiao-Yu Song, J&J Vision’s global head of R&D. “We will continue development of this contact lens technology and are committed to making regulatory submissions for this antihistamine-releasing contact lens as we move forward.”

Suggested Articles

J&J’s Ethicon unit received an FDA clearance for its Vistaseal applicators that spray a biologic sealant from Grifols to help stem surgical bleeding.

Gilead Sciences is paying Nurix $45 million upfront in a deal that could reach $2.3 billion in value if all milestones are met and royalties realized.

Bio-Techne’s urine test has received a breakthrough device designation from the FDA for ruling out unnecessary tissue biopsies.