PR Newswire06.23.21
Johnson & Johnson Vision,* a global leader in eye health and part of the Johnson & Johnson Medical Devices Companies,** has 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 Ketotifen.1 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, M.D., Ph.D., 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 eight 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 line of 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.
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.
* 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.
ǂ JJV Data on File 2018. U.S. Allergy Mobile Ethnography Study, with n=1,629 participating allergy sufferers
§ JJV Data on File 2015. U.S. 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
References
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).
"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, M.D., Ph.D., 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 eight 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 line of 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.
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.
* 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.
ǂ JJV Data on File 2018. U.S. Allergy Mobile Ethnography Study, with n=1,629 participating allergy sufferers
§ JJV Data on File 2015. U.S. 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
References
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).