J&J Vision Receives Canadian Approval for ACUVUE Abiliti Therapeutic Lenses

Johnson & Johnson Vision,† part of the Johnson & Johnson Medical Devices Companies,‡ has received approval from Health Canada for ACUVUE Abiliti 1-Day Soft Therapeutic Lenses for Myopia Management. Abiliti 1-Day lenses are a new option of daily wear, single-use, disposable lenses that have the potential to slow the progression of myopia and are specifically designed for children who are 7 to 12 years old at the start of treatment.§^1,3
 
“The approval from Health Canada for ACUVUE Abiliti 1-Day lenses marks another major step forward in our collaborative efforts with parents and eye care professionals to reshape the future of myopia,” said Xiao-Yu Song, M.D., Ph.D., global head of Research & Development, Johnson & Johnson Vision.** “Our researchers and scientists specifically designed Abiliti 1-Day to be a novel soft therapeutic lens with the potential to slow the progression of myopia in children.”¹
 
Abiliti 1-Day lenses are not traditional concentric ring presbyopic design lenses.¹ Abiliti 1-Day lenses are a breakthrough innovation specifically designed to slow myopia progression in children and have been shown to reduce axial elongation by 0.105 mm on average over a six-month period.††⁴ The lenses are built from silicone hydrogel (senofilcon A) lens material, the same material as ACUVUE OASYS 1-Day contact lenses, which have never been beaten in comfort.*²
 
The Health Canada approval for Abiliti 1-Day lenses marks another significant milestone for the Abiliti brand and Johnson & Johnson Vision. Abiliti will provide parents and eye care professionals with a set of products for myopia management. Earlier this year, the company also introduced ACUVUE Abiliti Overnight Therapeutic Lenses for Myopia Management in the United States. Abiliti Overnight lenses are specifically designed and fitted to match a patient’s eye based on its unique corneal shape to temporarily reshape the cornea.⁵ 
 
Myopia is sometimes called nearsightedness, but it is much more. It is a chronic and progressive disease that poses the biggest eye health threat of the 21st century.^6,7,8,9 Half of the world’s population is projected to be myopic by 2050 with nearly 1 billion people expected to have high myopia.¹⁰ Children under 12 who are diagnosed with myopia are at greater risk of developing high myopia which may lead to sight threatening disease later in life.¹¹ 
 
Abiliti 1-Day lenses are expected to be available in select areas of Canada starting as early as this year and expanding beyond in 2022. 
 
ACUVUE Abiliti 1-Day Soft Therapeutic Lenses for Myopia Management are intended for daily wear, worn on a daily disposable basis, for the correction of myopia (while the lenses are worn) and may slow myopia progression in children. The contact lenses are intended to be used by children who, at the initiation of treatment, are 7 to 12 years old, with myopia between -0.75D and -4.50D and 1.00D or less astigmatism, with non-diseased eyes and are symptomatic with regard to a need for distance vision correction. Slowing axial elongation and myopia progression was demonstrated in a clinical study of children between 7 and 12 years of age with a required lens wear time of, at a minimum, 8 hours per day and 5 days per week.†† Longer-term myopia control effect of the lens as well as permanent myopia control after lens treatment is discontinued has not been established through clinical trials.
 
Johnson & Johnson Vision, part of Johnson & Johnson Medical Devices Companies, has a bold ambition: to change the trajectory of eye health around the world. Through its operating companies, the firm delivers 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, Johnson & Johnson Vision works in collaboration to expand access to quality eye care, and we are committed to helping people see better, connect better and live better. 
 
Johnson & Johnson Medical Devices Companies builds on more than a century of expertise to 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, Johnson & Johnson Medical Devices Companies help save lives and pave the way to a healthier future for everyone, everywhere.
 
*www.clinicaltrials.gov is a website maintained by the NIH. The four clinical studies evaluated subjective comfort as a primary or secondary endpoint for ACUVUE OASYS Brand daily disposable family. Review conducted as of April 25, 2021.
†Johnson & Johnson Vision represents the products and services of Johnson & Johnson Surgical Vision Inc., Johnson & Johnson Vision Care Inc., and the affiliates of both.
‡Johnson & Johnson Vision represents the products and services of Johnson & Johnson Surgical Vision Inc., Johnson & Johnson Vision Care Inc., and the affiliates of both.
§Utilizing a smaller lens diameter designed to fit the smaller anatomical features of a pediatric population children (aged 7-12).
**Dr. Xiao-Yu Song is an employee of Johnson & Johnson Vision Care Inc., with oversight of research and development for both the Surgical Vision and Vision Care organizations.
†† Compared to single vision contact lenses after six months wear.

References 
¹ JJV Data on file, 2021. Development of Optical Design of ACUVUE Abiliti 1-Day Soft Therapeutic Lenses for Myopia Management.
² JJV Data on file 2021. Stand-alone Performance Claims; ACUVUE Abiliti 1-Day Soft Therapeutic Lenses for Myopia Management.
³ JJV Data on File 2021. Mechanical Design of ACUVUE Abiliti 1-Day Soft Therapeutic Lenses for Myopia Management- Effect on Fit and Handling.
⁴ JJV Data on file, 2021. Efficacy of ACUVUE Abiliti 1-Day Soft Therapeutic Lenses for Myopia Management: Comparative Claims vs. Single Vision and Dual Focus Lenses.
⁵ Data on File 2021. Menicon Design History file.
⁶ Flitcroft DI et al. IMI–Defining and classifying myopia: a proposed set of standards for clinical and epidemiologic studies. Invest Ophthalmol Vis Sci. 2019;60:M20-30.
⁷ Donovan L, Sankaridurg P, Ho A et al. Myopia progression rates in urban children wearing single-vision spectacles. OVS 2012;89(1):27-32.
⁸ Pärssinen O, Kauppinen M. Risk factors for high myopia: a 22-year follow-up study from childhood to adulthood. Acta Ophthalmologica. 2019;97(5):510-518.
⁹ Holy C, Kulkarni K, Brennan NA. Predicting Costs and Disability from the Myopia Epidemic – A Worldwide Economic and Social Model. Invest Ophthalmol Vis Sci.2019;60(9):5466-5466.
¹⁰ Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo K, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 to 2050. Ophthalmol.2016;123(5):1036-1042. doi: 10.1016/j.ophtha.2016.01.006. 
¹¹ Hu Y, Ding X, Guo X, Chen Y, Zhang J, He M. Association of Age at Myopia Onset with Risk of High Myopia in Adulthood in a 12-Year Follow-up of a Chinese Cohort. Jama Ophthalmol. 2020;138(11):1129-1134. doi:10.1001/jamaophthalmol.2020.3451.