Johnson & Johnson Vision Receives Approval in Canada for World's First and Only Drug-Releasing Contact Lens for Vision Correction and Allergic Eye Itch: ACUVUE® Theravision™ with Ketotifen
- Health Canada approves ACUVUE® Theravision™ with Ketotifen, the first drug-releasing contact lens that provides vision correction to people experiencing itchy allergy eyes.
JACKSONVILLE, Fla., April 27, 2021 /PRNewswire/ -- Johnson & Johnson Vision*, a global leader in eye health and part of the Johnson & Johnson Medical Devices Companies**, received Health Canada approval for the first and only daily disposable contact lens for vision correction in patients who experience itchy allergy eyes due to allergic conjunctivitis: ACUVUE® Theravision™ with Ketotifen1. The lens contains an H1 histamine receptor antagonist for the prevention of itchy allergy eyes associated with allergic conjunctivitis experienced by contact lens users to promote comfortable contact lens wear. In March 2021, ACUVUE® Theravision™ with Ketotifen received its first regulatory approval from the Japanese Ministry of Health, Labour and Welfare.
"We are proud to mark another step forward in delivering this important innovation to help relieve patients from allergic eye itch while continuing to comfortably wear contact lenses," said Xiao-Yu Song, MD, PhD, Global Head of Research & Development, Johnson & Johnson Vision***. "We look forward to working with additional health authorities to make ACUVUE® Theravision™ with Ketotifen available to more patients around the world."
Itchy allergy eyes can impact vision, and this becomes even more problematic for contact lens wearers – most of whom resort to rubbing their eyes.ǂ Data show that nearly 8 out of 10 contact lens wearers feel frustrated when their eye allergies interfere with normal contact lens wear.§ ACUVUE® Theravision™ with Ketotifen may help people continue to wear their contact lenses for vision correction, and prevent allergic eye itch, without the need for allergy eye drops.
ACUVUE® is the most trusted brand for eye care professionals globally^ and has built a legacy by making contact lenses that are unbeaten in comfort†,2,3,4 across 47 clinical studies.† ACUVUE® Theravision™ with Ketotifen is the latest in a long line of innovative contact lenses from Johnson & Johnson Vision since the company introduced the world's first daily disposable soft contact lens three decades ago. ACUVUE® Theravision™ with Ketotifen is the first in an entirely new contact lens category and brings forward a better contact lens wearing experience for patients with allergic eye itch.
About ACUVUE® Theravision™ with Ketotifen
ACUVUE® Theravision™ with Ketotifen contact lenses are a daily disposable contact lens for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic patients who are suitable for contact lens wear and experience ocular allergic itch due to allergic conjunctivitis and who do not have red eye(s) or more than 1.00 D of astigmatism. The lens contains an H1 histamine receptor antagonist for the prevention of itch associated with allergic conjunctivitis experienced by contact lens users to promote comfortable contact lens wear. The prevention of itch has been demonstrated to last through 12 hours in clinical trials; however, the lens may be worn for longer than 12 hours for vision correction. Pediatrics (12 years of age and older): The safety and efficacy of ACUVUE® Theravision™ with Ketotifen in pediatric patients has been established.
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 around the world. 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 and live better. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.
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, orthopedics, vision and interventional solutions, we are helping to save lives and paving the way to a healthier future for everyone, everywhere.
Important Information for Contact Lens Wearers
ACUVUE® Theravision™ with Ketotifen daily disposable contact lenses are available by prescription only for vision correction and relief of ocular allergic itch symptoms due to allergic conjunctivitis. An eye care professional will determine whether these contact lenses are right for you. Although rare, serious eye problems can develop while wearing contact lenses. Do not wear contact lenses if you have an eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or if your eye care provider has informed you that you are not suitable for contact lens wear due to severe allergic symptoms or other eye problems. If one of these conditions occurs, remove the lens, and contact your eye care professional immediately. For more information on proper wear, care, and safety, talk to your eye care professional, follow the Patient Instruction Guide, call 1-800-267-5098, or visit www.acuvue.ca.
©Johnson & Johnson Vision Care Inc., 2021. All rights reserved.
*Johnson & Johnson Vision represents the products and services of Johnson & Johnson Surgical Vision, Inc., Johnson & Johnson Vision Care, Inc., and the affiliates of both.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopedics, vision, and interventional solutions businesses within Johnson & Johnson's Medical Devices segment
***Dr. Xiao-Yu Song, MD, PhD is an employee of Johnson & Johnson Vision Care, Inc., with oversight of Research and Development for both the Surgical Vision and Vision Care organizations.
ǂJJV Data on File 2018. US Allergy Mobile Ethnography Study, with n=1,629 participating allergy sufferers
§JJV Data on File 2015. US and Japan Apollo Positioning Study, with n=801 participating allergy sufferers
^Survey among 1,150 Eye Care Professionals from the United States, United Kingdom, Russia, Japan, South Korea, China, France, and Germany conducted 12/2018 to 1/2019
†The following ACUVUE® Brand Contact Lenses have substantiated unbeaten in comfort claim: ACUVUE® OASYS Brand Family (including daily disposable), 1-DAY ACUVUE® MOIST Brand Family (within the category of hydrogel daily disposable), and ACUVUE® VITA® Brand Family2,3,4
1 JJV Data on File 2019. Mechanism of action, formulation, and comfort of ACUVUE® Theravision™ with Ketotifen
2 JJV Data on File 2021. Claim for the family of ACUVUE® OASYS Brand Contact Lenses (2-week reusable) and ACUVUE® OASYS 1-Day with HydraLuxe® Technology using clinical trials cited on www.clinicaltrials.gov website (February 25, 2021).
3 JJV Data on File 2020. Claim for ACUVUE® VITA® with HydraMax® Technology. Unbeaten in Comfort in Monthly Lens Category - using clinical trials cited on www.clinicaltrials.gov website (November 23, 2020).
4 JJV Data on File 2020. Unbeaten Comfort of 1-DAY ACUVUE® MOIST Family Brand Contact Lenses (December 21, 2020).
SOURCE Johnson & Johnson Vision
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