Johnson & Johnson Vision Announces FDA Approval of ACUVUE® Abiliti™ Overnight Therapeutic Lenses for Myopia Management

JACKSONVILLE, Fla., May 12, 2021 /PRNewswire/ -- Johnson & Johnson Vision,* a global leader in eye health and part of the Johnson & Johnson Medical Devices Companies,^† today announced that the U.S. Food and Drug Administration (FDA) has approved ACUVUE^® Abiliti™ Overnight Therapeutic Lenses for Myopia Management. Abiliti™ Overnight orthokeratology (ortho-k) lenses are specifically designed and fitted match a patient's eye based on its unique corneal shape to temporarily reshape the cornea.^1,2

"The FDA approval of Abiliti™ Overnight lenses marks an important milestone in our commitment to help change the trajectory of eye health," said Xiao-Yu Song, MD, PhD, Global Head of Research & Development, Johnson & Johnson Vision.^‡ "We look forward to supporting patients and eye care professionals with comprehensive resources, starting with Abiliti™ Overnight lenses, and continuing with additional products and services to address myopia management."

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.^3,4,5,6 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.⁷ Additionally, half of the world's population is projected to be myopic by 2050 with nearly one billion people expected to have high myopia.⁸

Clinical studies have demonstrated that ortho-k lenses can be a safe and effective treatment option to manage myopia.⁹ Abiliti™ Overnight lenses are optimized by the use of corneal topography, refractive error and other measurements connected to an experiential fitting software, FitAbiliti™.² The FitAbiliti™ software guides the eye care professional through the fitting process and recommends a lens with the first fit success rate of approximately 90%.^§2 Abiliti™ Overnight lenses will be available in two different contact lens designs: ACUVUE^® Abiliti™ Overnight Therapeutic Lenses for Myopia Management, and ACUVUE^® Abiliti™ Overnight Therapeutic Lenses for Myopia Management for Astigmatism.¹⁰

"The prevalence of myopia in children is increasing, and as optometrists we are on the front lines of this epidemic that may threaten the vision of future generations," said Moshe Mendelson, OD, FIAO.^** "The FDA approval of Abiliti™ Overnight lenses will provide eye care professionals and parents with more options to manage myopia."

Johnson & Johnson Vision is collaboratively advancing the next generation of science, research and development with the potential to transform standards of care in myopia. The FDA approval of Abiliti™ Overnight lenses stems from the collaboration of Johnson & Johnson Vision with Menicon to bring forward therapeutic contact lenses for myopia management under the Abiliti™ brand. The Abiliti™ portfolio is a growing suite of solutions designed to manage myopia. Our goal is to develop products that give clearer vision today and better eye health in the future.

Each annual purchase of an Abiliti™ product will provide a free comprehensive eye health exam to a child in need through Sight For Kids^® – a joint program from Johnson & Johnson Vision^* and the not-for-profit Lions Clubs International Foundation (LCIF). Sight For Kids^® is one of the largest-known, school-based eye health programs that mobilizes LCIF and eye care professionals to provide comprehensive eye health services in low-income schools around the world.

Abiliti™ Overnight contact lenses are expected to be available in the U.S. by the end of 2021. Patients and eye care professionals who want more information can visit www.seeyourabiliti.com.

About ACUVUE^® Abiliti™ Overnight Therapeutic Lenses for Myopia Management
ACUVUE^® Abiliti™ Overnight Therapeutic Lenses for Myopia Management are orthokeratology lenses approved by the U.S. Food and Drug Administration (FDA) for myopia management. Abiliti™ Overnight lenses are worn overnight to reduce refractive error up to 4.00 D (and up to 1.50D of astigmatism), and subject to the eye care professional's myopia management plan, may eliminate the need to wear contact lenses or glasses throughout the waking hours after lenses are removed.¹⁰

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^® Abiliti™ Overnight Therapeutic Lenses for Myopia Management are available by prescription only for the management of myopia. 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.  To help avoid these symptoms, follow the wear and replacement schedule and the lens care disinfection instructions provided by your eye doctor. Do not wear these contact lenses if you have an eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or other eye problems.  If one of these conditions occurs, remove the lens and contact to your eye care professional immediately. 

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^* 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.
^§ Final lens fit is determined by the ECP – software is a decision support only.
^**  Dr. Moshe Mendelson is a paid consultant of Johnson & Johnson Vision, Inc.
¹ JJV Data on File 2021. Menicon Design History File.
² JJV Data on File 2021. ACUVUE^® Abiliti™ Overnight Therapeutic Lenses for Myopia Management - Consolidated, Approved Claims List; U.S. Only Claims
³ 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.
⁴ Donovan L, Sankaridurg P, Ho A et al. Myopia progression rates in urban children wearing single-vision spectacles. OVS 2012;89(1):27-32.
⁵ 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.
⁶ 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.
⁷ 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.
⁸ 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.
⁹ JJV Data on File 2021. Instructions for Use (FDA).
¹⁰ JJV Data on File 2021. P990018/S006. FDA Technical File.

SOURCE Johnson & Johnson Vision