Johnson & Johnson Vision Care Receives FDA Clearance for ACUVUE® Theravision™ and Ketotifen

New Technology Combines ACUVUE® Daily Disposable Contact Lenses with FDA-Established Antihistamines—First in Its New Class
JACKSONVILLE, Fla., March 2, 2022 /PRNewswire/ — Johnson & Johnson Vision Care*, a global leader in eye health, a division of Johnson & Johnson Medical Devices† today announced that the U.S. Food and Drug Administration ( FDA) has approved ACUVUE® Theravision™ with ketotifen (etafilcon A drug eluting contact lenses with ketotifen).Each lens contains 19 micrograms of ketotifen.Ketotifen is a well-established antihistamine.ACUVUE® Theravision™ with Ketotifen is the first in a new contact lens category, bringing a new wearing experience to contact lens wearers with allergic itchy eyes.
ACUVUE® Theravision™ with ketotifen is a daily disposable contact lens indicated for the prevention of eye itching due to allergic conjunctivitis and to provide vision correction for patients without red eye, suitable for contact lens wear, and visual acuity less than 1.00 D Astigmatism .

1800 contact lenses

1800 contact lenses
Approximately 40% of contact lens wearers in the U.S. have itchy eyes due to eye allergies‡, and nearly 8 in 10 contact lens wearers with eye allergies agree that when allergies interfere with their normal contact lens When wearing it, they get frustrated.§ Although allergy eye drops are a very common treatment, 1 in 2 contact lens wearers report that these eye drops are inconvenient to use.**
Today’s announcement follows an active Phase 3 clinical study published in the Journal of Cornea and regulatory approvals from Japan’s Ministry of Health, Labour and Welfare and Health Canada, with the new lenses already available to patients.1 According to a Phase 3 clinical study, ACUVUE® Theravision™ with ketotifen demonstrated a clinically and statistically significant reduction in pruritus symptoms in allergic eyes within 3 minutes of lens insertion for up to 12 hours; However, to correct vision, the lenses can be worn for more than 12 hours.
“Thanks to the FDA’s decision to approve ACUVUE® Theravision™ with Ketotifen, allergic itch in contact lens wearers may soon be a thing of the past,” said Brian Pall, director of clinical sciences at Johnson & Johnson.Johnson Vision Care.†† “These new lenses may help keep more people wearing contact lenses because they relieve allergic eye itching for up to 12 hours, eliminate the need for allergy drops, and provide vision correction.”
“At Johnson & Johnson Vision, we are committed to introducing new technologies and innovations that improve vision and overall eye health,” said Thomas Swinnen, president of Johnson & Johnson Vision Care North America.‡‡ “This approval marks another important milestone for J&J Vision in rethinking what’s possible with contact lenses to meet the vision and eye health needs of people around the world.”
ACUVUE® Theravision™ with ketotifen are daily wear, daily disposable drug-eluting contact lenses that contain an antihistamine to prevent eye itching caused by allergic conjunctivitis and correct flexion in patients without red eye. Optical refractive error, suitable for contact lenses and astigmatism not exceeding 1.00 D.
Eye problems, including corneal ulcers, can develop rapidly and cause vision loss.If you encounter:
If you have any of these conditions, or don’t know if you have any of these conditions, talk to your healthcare provider.
For the health of your eyes, be sure to carefully follow the handling, insertion, removal, and warning instructions in the Patient Guidance Guide, as well as your eye care professional’s instructions.

Always tell your employer that you are a contact lens wearer.Some jobs may require the use of eye protection or may require you not to wear contact lenses.
ACUVUE® Theravision™ with Ketotifen is prescribed by your eye care professional for daily single use and should be discarded after each should:
If you use a spray (spray) product, such as hairspray, while wearing your lenses, close your eyes until the spray is completely gone.
Never rinse lenses in tap water.Tap water contains many impurities that can contaminate or damage your lenses and can lead to eye infection or injury.
Lubrication/rewetting solutions should not be used with these lenses.If the lens sticks (stops moving), a few drops of non-preserved sterile saline can be used to help with removal.
Do not lubricate or rewet the lenses with saliva or anything other than the recommended solution.Do not put the lens in your mouth.
Never let other people wear your lenses.Sharing lenses greatly increases the chance of eye infections.
Never wear your lenses for the time recommended by your eye care professional.Wear no more than one lens per day.
The most common ocular adverse reactions in clinical studies occurred in <2% of treated eyes and were eye irritation, eye pain, and instillation site irritation.
Be aware that problems with wearing contact lenses can occur and may be related to the following symptoms:
When any of these symptoms occur, serious eye disease can develop.If necessary, you should see your eye care professional right away to identify and treat the problem to avoid serious eye damage.
This product should not be used to treat or prevent lens-related symptoms, including irritation, discomfort or redness.
If you notice any problems, you should immediately remove your lenses and contact your eye care professional.
These lenses do not require cleaning or disinfection.Always discard lenses when removing them and have replacement non-medicated lenses or glasses ready.Any unused product or waste should be disposed of in accordance with local requirements.

1800 contact lenses

1800 contact lenses
If chemicals of any kind (household products, gardening solutions, laboratory chemicals, etc.) are splashed into eyes: Immediately flush eyes with running water and contact your eye care professional or go to a hospital emergency room immediately.
Tell your eye care professional if you have any side effects that bother you or that don’t go away.
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Post time: Mar-19-2022