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Johnson & Johnson Vision Receives Approval of World's First and Only Drug-Releasing Combination Contact Lens for Vision Correction and Allergic Eye Itch: ACUVUE® Theravision™ with Ketotifen

- The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the first combination contact lens that provides vision correction and an antihistamine drug to help relieve symptoms for people experiencing itchy allergy eyes: ACUVUE® Theravision™ with Ketotifen.

- This is the first regulatory approval by any health authority for the novel technology, which combines an ACUVUE® daily disposable contact lens (etafilcon A) with ketotifen, an established antihistamine.


News provided by

Johnson & Johnson Vision

Mar 24, 2021, 08:00 ET

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JACKSONVILLE, Fla., March 24, 2021 /PRNewswire/ -- Johnson & Johnson Vision*, a global leader in eye health and part of the Johnson & Johnson Medical Devices Companies**, today announced approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the first and only vision correction contact lens that relieves allergic eye itch: ACUVUE® Theravision™ with Ketotifen.1 The lens contains ketotifen, an H1 histamine receptor antagonist for the prevention of itch associated with eye allergies. 

"This approval marks another significant milestone in Johnson & Johnson Vision's legacy of rethinking what's possible with contact lenses, and bringing forward innovations to help eye care practitioners better meet the needs of their patients around the world," said Xiao-Yu Song, MD, PhD, Global Head of Research & Development, Johnson & Johnson Vision***. "Our goal at Johnson & Johnson Vision is to change the trajectory of eye health and we will continue to drive new innovation and technologies that correct, enhance, and restore people's vision over their lifetimes."

Itchy allergy eyes can impact vision, and this becomes even more problematic for contact lens wearers – most of whom resort to rubbing their eyes. Data show that 8 out of 10 contact lens wearers feel frustrated when their eye allergies interfere with normal contact lens wear.2 ACUVUE® Theravision™ with Ketotifen may help patients who wish to continue wearing contact lenses during the allergy season.

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†3,4,5 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 disposable soft contact lens three decades ago. This product 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.

"Over 40 percent of people suffer from eye allergies, and of those, 80 percent feel frustrated when allergies interfere with contact lens wear2," said Dr. Brian Pall, OD, MS, FAAO, Director, Clinical Science, Johnson & Johnson Vision Care, Inc****. "We're proud to bring forward a new contact lens that simultaneously provides vision correction and relief of allergic eye itch, without the need for allergy eye drops."

Johnson & Johnson Vision is working with health authorities worldwide to bring ACUVUE® Theravision™ with Ketotifen to contact lens wearers seeking relief from allergic eye itch.

About ACUVUE® Theravision™ with Ketotifen
ACUVUE® Theravision™ with Ketotifen has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) as a daily disposable contact lens for vision correction, and alleviation of ocular allergic symptoms during contact lens wear in patients with allergic conjunctivitis.

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 Safety Information for Contact Lens Wearers
ACUVUE® Theravision™ with Ketotifen daily disposable contact lenses are approved in Japan for vision correction, and alleviation of ocular allergic symptoms during contact lens wear in patients with allergic conjunctivitis. Contact lenses are highly controlled medical devices. Be sure to consult an eye care professional in advance to receive tests and prescriptions. Please read the package insert carefully before using contact lenses and follow the instructions for handling them. For more information on proper wear, care, and safety, talk to your eye care professional and follow the Patient Instruction Guide.

____________________

*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.

^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 spherical only 3, 4, 5.

§Compared to a traditional contact lens

****Dr. Brian Pall, OD, MS, FAAO is an employee of Johnson & Johnson Vision Care, Inc., as the Director of Clinical Science

1JJV Data on File 2019. Mechanism of action, formulation, and comfort of ACUVUE® Theravision™ with Ketotifen

2 JJV Data on File 2019 U.S. & Canada Ocular Allergy - Key Insights Review

3 JJV Data on File 2020. 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).

4 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).

5 JJV Data on File 2020. Unbeaten Comfort of 1-DAY ACUVUE® MOIST Family Brand Contact Lenses (December 21, 2020).

Johnson & Johnson K.K. 2021. All rights reserved.

SOURCE Johnson & Johnson Vision

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