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  • FDA approves first...

FDA approves first drug-eluting contact lens with antihistamine for itchy eyes

Written By : Dr. Kamal Kant Kohli Published On 2022-03-04T08:15:21+05:30  |  Updated On 4 March 2022 8:21 AM IST
FDA approves first drug-eluting contact lens with antihistamine for itchy eyes

CAPTION

Rose-tinted contact lenses (about 10 mm in diameter) containing gold nanoparticles filter out problematic colors for people with red-green color blindness.

CREDIT

Adapted from ACS Nano 2021, DOI: 10.1021/acsnano.0c09657

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The US food and drug administration has approved first drug-eluting contact lens containing an antihistamine for people with allergic eye itch.

ACUVUE® Theravision™ with Ketotifen (etafilcon A drug-eluting contact lens with ketotifen) contains 19 mcg ketotifen. Ketotifen is a well-established antihistamine. ACUVUE® Theravision™ with Ketotifen is the first in an entirely new category of contact lenses and brings forward a new wearing experience for contact lens wearers with allergic eye.
The food and drug administration has granted approval to Johnson & Johnson Vision Care.
ACUVUE® Theravision™ with Ketotifen are daily wear, daily disposable drug-eluting contact lenses containing an antihistamine to prevent ocular itch due to allergic conjunctivitis and correction of refractive ametropia in patients who do not have red eyes, who are suitable for contact lens wear and who do not have more than 1.00 D of astigmatism.

Within the U.S., approximately 40 percent of contact lens wearers suffer from itchy eyes due to ocular allergies,‡ and nearly 8 out of 10 contact lenses wearers with eye allergies agree that they are frustrated when allergies interfere with their normal contact lens wear.§ While allergy eye drops are a very common treatment, 1 in 2 contact lens wearers say that the drops are inconvenient to use.**

Today's announcement follows positive Phase 3 clinical studies published in the journal Cornea and regulatory approval by the Japanese Ministry of Health, Labor and Welfare, and Health Canada, where patients already have access to the new lenses.1 According to the Phase 3 clinical studies, ACUVUE® Theravision™ with Ketotifen showed a clinically and statistically meaningful reduction in itchy allergy eyes as quickly as 3 minutes after lens insertion and lasting up to 12 hours; however, the lens may be worn for longer than 12 hours for vision correction.

"Ocular allergic itch in contact lens wearers may soon be an issue of the past thanks to the decision of the FDA in approving ACUVUE® Theravision™ with Ketotifen," said Brian Pall, OD, MS, FAAO, Director, Clinical Science, Johnson & Johnson Vision Care.†† "These new lenses may help keep more people in contact lenses, since they relieve allergic eye itch for up to 12 hours, without the need for allergy drops, and provide vision correction."

"At Johnson & Johnson Vision, we are committed to bringing forward new technologies and innovations that can improve vision and overall eye health," said Thomas Swinnen, President, North America, Johnson & Johnson Vision Care, Inc.‡‡ "This approval marks another significant milestone in Johnson & Johnson Vision's legacy of rethinking what's possible with contact lenses to meet the visual and eye health needs of people around the world."

FDAfda approvaldrug-eluting contact lensantihistamineitchy eyescontact lensfood and drug administration
Dr. Kamal Kant Kohli
Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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