JACKSONVILLE, Fla.—Johnson & Johnson Vision said Wednesday that the Food and Drug Administration (FDA) has approved Acuvue Abiliti Overnight Therapeutic Lenses. This new lens is the first and only FDA approved orthokeratology (ortho-k) contact lens for the management of myopia, according to the announcement. The lens, expected to launch by the end of 2021, will be available in sphere and toric designs to correct various combinations of corneal shapes and refractive errors. ECPs and parents who want more information can visit the site here.

The FDA approval of Abiliti Overnight stems from the collaboration between J&J Vision and Menicon to bring forward therapeutic contact lenses for the treatment of myopia under the Acuvue Abiliti Brand, which J&J Vision said is a “new  brand for future products and services to help parents and eyecare professionals address the progression of myopia in children.” VMAIL reported on this collaboration last month.

“The FDA approval of Abiliti Overnight 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 eyecare professionals in their care of children with comprehensive resources, starting with Abiliti Overnight Therapeutic Lenses, and continuing with additional products and services to address the progression of myopia."

Clinical studies have demonstrated that ortho-k lenses can be a safe and effective treatment option to manage myopia, according to J&J Vision.

Abiliti Overnight ortho-k contact lenses are specifically designed and fitted to match the eye based on its unique corneal shape to temporarily reshape the cornea. Abiliti Overnight will be available in two different contact lens designs: Abiliti Overnight 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 eyecare professional through the fitting process for consistent and successful first fit rates of approximately 90 percent.

"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 Abiliti Overnight will provide eye are professionals and parents with more options to manage myopia.”

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 eyecare professionals to provide comprehensive eye health services in low-income schools around the world.