ACUVUE Abiliti Overnight Therapeutic Lenses for Myopia Management Receives FDA Approval

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ACUVUE Abiliti Overnight Therapeutic Lenses has received U.S. Food and Drug Administration (FDA) approval reports Johnson & Johnson Vision.

This is the first and only FDA-approved orthokeratology (ortho-k) contact lens for the management of myopia.

“The FDA approval of AbilitiOvernight marks an important milestone in our commitment to help change the trajectory of eye health and reshape the future of children with myopia,” said Xiao-Yu Song, MD, PhD, Global Head of Research & Development, Johnson & Johnson Vision. “We look forward to supporting parents and eye care professionals in their care of children with comprehensive resources, starting with AbilitiOvernight Therapeutic Lenses, and continuing with additional products and services to address the progression of myopia.”

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 Century1. Young children that are less than 12 years of age and become myopic are the most vulnerable to develop high myopia and can be at increased risk of sight-threatening eye diseases later in life2. Additionally, half of the world’s population is projected to be myopic by 2050 with nearly one billion people expected to have high myopia.

Clinical studies have demonstrated that ortho-k lenses can be a safe and effective treatment option to manage myopia. AbilitiOvernight ortho-k contact lenses are specifically designed and fitted to match the eye based on its unique corneal shape to temporarily reshape the cornea8. Abiliti Overnight will be available in two different contact lens designs: AbilitiOvernight Therapeutic Lenses, and Abiliti Overnight Therapeutic Lenses for Astigmatism.

Abiliti Overnight contact lenses are optimized by the use of corneal topography, refractive error and other measurements connected to an innovative fitting software. The software is a sophisticated and user-friendly tool that provides a precise measure of the corneal shape, and accurately guides the eye care professional through the fitting process for consistent and successful first fit rates of approximately 90%

“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. “For too long we have relied on increasing the prescription of glasses for children, while having few resources to address the underlying disease and help change this worrying trajectory of eye health. The FDA approval of AbilitiOvernight 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. Earlier this year, the company announced the development of a first-of-its-kind myopia management guide with recommendations for eye care professionals to assess, monitor and treat myopia in children. The FDA approval of Abiliti Overnight stems from the collaboration of Johnson & Johnson Vision with Menicon to bring forward therapeutic contact lenses for the treatment of myopia under the ACUVUE® Abiliti Brand – a new brand for future products and services to help parents and eye care professionals address the progression of myopia in children.

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 program from the 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.

ACUVUE Abiliti Overnight contact lenses are expected to be available in the U.S. by the end of 2021. Parents and eye care professionals who want more information can visit here.

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