March 2, 2022

Johnson & Johnson Vision Care Receives FDA Approval for ACUVUE® Theravision™ with Ketotifen – World’s First and Only Drug-Eluting Contact Lens

Novel technology combines ACUVUE^® daily disposable contact lenses with an established antihistamine in FDA- first in its new category

JACKSONVILLE, FL –March 2, 2022 – Johnson & Johnson Vision Care, Inc.¹, a global leader in eye health and part of the Johnson & Johnson Medical Device Companies,² today announced that the U.S. Food and Drug Administration (FDA) has approved ACUVUE^® Theravision™ with Ketotifen (etafilcon A drug-eluting contact lens with ketotifen). Each lens 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 itch.

ACUVUE^® Theravision™ with Ketotifen are daily disposable contact lenses indicated for the prevention of ocular itch due to allergic conjunctivitis and provide vision correction 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,³ 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.⁴ While allergy eye drops are a very common treatment, 1 in 2 contact lens wearers say that the drops are inconvenient to use.⁵

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.⁶ 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.⁷ “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.⁸ “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.”

For more information and to stay informed of product availability, please visit: www.acuvuetheravision.com. For full Prescribing Information, please click here and to view the Patient Instruction Guide click here.

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About ACUVUE^® Theravision™ with Ketotifen

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.

IMPORTANT SAFETY INFORMATION

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ACUVUE^® Theravision™ with Ketotifen?

Eye problems, including corneal ulcers, can develop rapidly and lead to loss of vision. If you experience:

Eye discomfort,
Excessive tearing,
Vision changes,
Loss of vision,
Eye redness, or
Other eye problems.

You should immediately remove the lenses, and promptly contact your eye care professional.

These lenses should not be used to treat red eye(s). Remove lens(es) immediately if your eyes become red or irritated.
Lenses prescribed for daily disposable wear (i.e., your Eye Care Professional instructs you to remove and discard your lenses at the end of each day), should not be worn while sleeping. Clinical studies have shown the risk of serious eye problems is increased when lenses are worn overnight.
Contact lens wearers who are smokers have a higher incidence of corneal ulcers than nonsmokers.
Problems with contact lenses or lens care products could result in serious injury to the eye.
Proper use and care of your contact lenses are essential for the safe use of these products.
The overall risk of serious eye problems may be reduced by carefully following directions for lens care.
Water activity – do not expose your contact lenses to water while you are wearing them. Water can harbor microorganisms that can lead to severe infection, vision loss, or blindness. If your lenses have been submersed in water when participating in water sports or swimming in pools, hot tubs, lakes, or oceans, you should discard them and replace them with a new pair. Ask your Eye Care Professional for recommendations about wearing your lenses during any activity involving water.

Do not use ACUVUE^® Theravision™ with Ketotifen when you have any of the following conditions:

Red or irritated eye(s): Remove contact lenses immediately if eyes become red while wearing
Inflammation or infection in or around the eye or eyelids
Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids
Any previously diagnosed condition that makes contact lens wear uncomfortable
Severe dry eye
Reduced corneal sensitivity
Any systemic (congenital) disease that may affect the eye or be made worse by wearing contact lenses
Allergic reactions on the surface of the eye or surrounding tissues that may be induced or made worse by wearing contact lenses
Any active eye infection
Known hypersensitivity to any ingredient in this product

Talk to your healthcare provider if you have any of these conditions, or do not know if you have any of these conditions.

WHAT SHOULD I KNOW BEFORE USING ACUVUE^® Theravision™ with Ketotifen?

For your eye health, it is important to carefully follow the handling, insertion, removal, and warning instructions in the Patient Instruction Guide, as well as those prescribed by your Eye Care Professional.

Do not use contact lens care solutions with this product
If you wear your contact lenses to correct Presbyopia using monovision, you may not be able to get the best corrected visual acuity for either far or near vision. Visual needs are different for different people, so your Eye Care Professional should work with you when selecting the most appropriate type of lens for you.
Always contact your Eye Care Professional before using any medicine in your eyes.
Be aware that certain medications, such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, oral contraceptives, and those for motion sickness may cause dryness of the eye, increased lens awareness (feeling of the lens in the eyes), or blurred vision. Always inform your Eye Care Professional if you experience any problems with your lenses while taking such medications.
Do not change lens type (e.g., brand name, etc.) or parameters (e.g. diameter, base curve, lens power, etc.) without consulting your Eye Care Professional.
Consult your Eye Care Professional or Health Care Provider if you are pregnant or nursing a baby.
As with any contact lens, follow-up visits are necessary to assure the continuing health of your eyes. Ask your Eye Care Professional about the recommended follow-up schedule.

Who should know that you are wearing contact lenses?

Inform all of your doctors (Health Care Professionals) about being a contact lens wearer.

Always inform your employer of being a contact lens wearer. Some jobs may require use of eye protection equipment or may require that you not wear contact lenses.

WHAT SHOULD I KNOW ABOUT WEARING ACUVUE^® Theravision™ with Ketotifen?

DO NOT WEAR YOUR LENSES WHILE SLEEPING.

ACUVUE^® Theravision™ with Ketotifen are prescribed by your Eye Care Professional for daily disposable wear and are to be discarded after each removal. You should:

Insert one lens per eye per day. Discard lens after a single day’s use.
If prevention or relief of itching is needed beyond twelve hours, consult your Eye Care Professional.
These lenses may be worn beyond twelve hours for vision correction. Lenses should be removed prior to sleeping.
Do not use contact lens cleaning and disinfectant solutions with ACUVUE^® Theravision™ with Ketotifen.

What precautions should I follow while wearing my lenses?

Hazardous Conditions

If you use aerosol (spray) products, such as hair spray, while wearing lenses, keep your eyes closed until the spray has settled.

Avoid all harmful or irritating vapors and fumes while wearing lenses.

Never rinse your lenses in water from the tap. Tap water contains many impurities that can contaminate or damage your lenses and may lead to eye infection or injury.

Water Activity

Do not expose your contact lenses to water while you are wearing them.

Lubricating/Rewetting Solutions

Lubricating/Rewetting solutions should not be used with these lenses. IF the lens sticks (stops moving), a few drops of non-preserved sterile saline may be applied to assist with removal.

Do not use saliva or anything other than the recommended solutions for lubricating or rewetting your lenses. Do not put lenses in your mouth.

Sharing Lenses

Never allow anyone else to wear your lenses. Sharing lenses greatly increases the chance of eye infections.

Adhering to the Prescribed Wearing & Replacement Schedules

Never wear your lenses beyond the amount of time recommended by your Eye Care Professional. Never wear more than one lens per day.

Always throw away worn lenses as prescribed by your Eye Care Professional.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF ACUVUE^® Theravision™ with Ketotifen contact lenses?

Possible Problems

The most commonly observed ocular adverse reactions in clinical studies occurring in <2% of treated eyes, were eye irritation, eye pain, and installation site irritation.

Other Contact Lens Related Problems

Be aware that problems can occur while wearing contact lenses and may be associated with the following symptoms:

Burning, stinging, itchy, and/or dry eyes
Reduced lens comfort
Feeling of something in your eye (foreign body, scratched area)
Swelling or inflammation in or around the eyes
Eye redness
Eyelid problems
Watery eyes and/or unusual eye secretion
Poor vision
Blurred vision
Rainbows or halos around objects
Sensitivity to light (photophobia)

When any of these symptoms occur, a serious eye condition may be present. You should immediately be seen by your Eye Care Professional, so that the problem can be identified and treated, if necessary, in order to avoid serious eye damage.

This product should not be used to treat or prevent lens-related symptoms including irritation, discomfort, or redness.

Recognizing Problems and What to Do

You should conduct a simple 3-part self-examination at least once a day. Ask yourself:

How do the lenses feel on my eyes?
How do my eyes look?
Have I noticed a change in my vision?

If you notice any problems, you should IMMEDIATELY REMOVE YOUR LENSES AND CONTACT YOUR EYE CARE PROFESSIONAL.

HOW SHOULD I CARE FOR MY LENSES?

There is no cleaning or disinfection needed with these lenses. Always dispose of lenses when they are removed and have replacement non-medicated lenses or glasses available. Any unused product or waste material should be disposed of in accordance with local requirements.

Lens Storage:

Store these lenses at room temperature
These lenses are sensitive to light – store individual blister packages in the carton until use.

WHAT TO DO IN CASE OF EMERGENCY

If chemicals of any kind (household products, gardening solutions, laboratory chemicals, etc.) are splashed into eyes: FLUSH EYES IMMEDIATELY WITH TAP WATER AND IMMEDIATELY CONTACT YOUR EYE CARE PROFESSIONAL OR VISIT A HOSPITAL EMERGENCY ROOM RIGHT AWAY.

Tell your Eye Care Professional if you have any side effect that bothers you or that does not go away.

Call your Eye Care Professional for medical advice about side effects. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Johnson & Johnson Vision Care, Inc. at 1-800-843-2020.

Please see full Prescribing Information and Patient Instruction Guide.

Trademarks are those of their respective owners.

About Johnson & Johnson Vision*
At Johnson & Johnson Vision*, part of Johnson & Johnson Medical Devices Companies, we have a bold ambition: to change the trajectory of eye health worldwide. Through our operating companies, we deliver innovation that enables eye care professionals to create better outcomes for patients throughout their lives, with products and technologies that address unmet needs including refractive error, cataracts, and dry eye. In communities with greatest need, we work in collaboration to expand access to quality eye care, and we are committed to helping people see better, connect better, live better. Visit us at jjvision.com, follow @JNJVision on Twitter, Johnson & Johnson Vision on LinkedIn, and @JNJVision on Facebook.

About Johnson & Johnson Medical Devices Companies**
At Johnson & Johnson Medical Devices Companies, we are helping people live their best lives. Building on more than a century of expertise, we tackle pressing healthcare challenges, and take bold steps that lead to new standards of care while improving people’s healthcare experiences. In surgery, orthopaedics, vision, and interventional solutions, we are helping to save lives and paving the way to a healthier future for everyone, everywhere.

1. Johnson & Johnson Vision represents the products and services of Johnson & Johnson Surgical Vision, Inc., Johnson & Johnson Vision Care, Inc., and the affiliates of both.
2. The Johnson & Johnson Medical Device Companies comprise the surgery, orthopedics, vision, and interventional solutions businesses within Johnson & Johnson's Medical Devices segment.
3. JJV Data on File 2019. Online consumer allergy landscape survey of patients self-identifying as eye allergy sufferers within the USA (n=1212)
4. JJV Data on File 2019. Online consumer allergy landscape survey of patients self-identifying as eye allergy sufferers within the USA (n=521)
5. JJV Data on File 2019. Online consumer allergy landscape survey of patients self-identifying as eye allergy sufferers within the USA (n=293)
6. Pall, B., Gomes, P., Yi, F., & Torkildsen, G. (2019). Management of Ocular Allergy Itch With an Antihistamine-Releasing Contact Lens. Cornea, 38(6), 713–717. https://doi.org/10.1097/ICO.0000000000001911
7. Brian Pall, OD, MS, FAAO, is an employee of Johnson & Johnson Vision Care, Inc. with oversight as Director of Clinical Science of the Vision Care organization.
8. Thomas Swinnen is an employee of Johnson & Johnson Vision Care, Inc.

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