Johnson & Johnson Vision's ACUVUE® Abiliti™ Overnight Orthokeratology Contact Lenses Receive FDA Approval for Myopia Management

JACKSONVILLE, Fla., May 20, 2021 /PRNewswire/ -- Johnson & Johnson's eye health business -- Johnson & Johnson Vision announces that its ACUVUE^® Abiliti™ overnight wear contact lenses have been approved by the U.S. Food and Drug Administration (FDA). This isThe first and currently onlyFDA-approvedIndicationsContact lenses for myopia management.

“JOHNSON & JOHNSON VISION remains committed to changing the trajectory of eye health and reshaping the future of childhood myopia. The FDA approval of the Abiliti™ overnight wear contact lens marks a significant milestone on our journey toward realizing this vision,” said Dr. Xiaoyu Song, Global Head of R&D at JOHNSON & JOHNSON VISION. “We look forward to providing comprehensive resource support for parents and eye care professionals. ACUVUE^®The launch of the Abiliti™ overnight therapeutic contact lenses is just the beginning, and we will continue to provide more products and services,ForAddress the progression of myopia.”

Myopia is a chronic progressive disease and has become the greatest threat to eye health in the 21st century.^[1]。Children aged 12 years and under who develop myopia are highly susceptible to progressing to high myopia, which may increase their risk of blinding eye diseases in later life.^[2]. It is projected that by 2050, half of the global population will be affected by myopia, with approximately 1 billion individuals having high myopia.^[3]。

Clinical studies demonstrate that contact lenses are a safe and effective treatment option for myopia management.^[4]Abiliti™ overnight orthokeratology contact lenses are custom-designed based on an individual's unique corneal shape to fit different eyes.^[4]。The Abiliti™ Overnight will offer two different contact lens designs, including the Abiliti™ Overnight Therapeutic Contact Lens and the Abiliti™ Overnight Toric Therapeutic Contact Lens.

Abiliti™ overnight wear corneal contact lenses integrate corneal topography, refractive error, and other clinical examinations with an innovative fitting software. This software is a sophisticated yet user-friendly tool,Used forEvaluate corneal shape and provide accurate guidance to eye care professionals during the fitting process, thereby consistently achieving a 90% first-fit success rate.

“The prevalence of childhood myopia continues to rise. As optometrists, we are working on the front lines to combat this epidemic that threatens the ocular health of the next generation,” said Dr. Moshe Mendelson, OD, Fellow of the International Academy of Orthokeratology. “For a long time, we have relied on fitting children with conventional spectacles, yet lacked sufficient resources to manage this progressive condition and help alter the adverse trajectory of their ocular health. The FDA approval of the Abiliti™ overnight orthokeratology contact lenses will provide eye care professionals and parents with additional options for myopia management.”

Johnson & Johnson Vision is actively pursuing collaborations to accelerate the research and development of innovative technologies and solutions, aiming to bring transformative change to myopia management and reshape the trajectory of eye health. Earlier this year, the company announced the launch of a new guideline—the first of its kind—designed to provide myopia management recommendations for eye care professionals,Used forEvaluate, monitor, and treat pediatric myopia. The FDA approval of the Abiliti™ overnight wear contact lens stems from the previous strategic partnership between Johnson & Johnson Vision and Menicon, through ACUVUE^®The Abiliti™ brand launches therapeutic corneal contact lenses,ForTreats myopia. Under the new Abiliti™ brand, the company will launch a series ofForProducts and services that help parents and eye care professionals manage the progression of myopia in children.

For every one-year supply of Abiliti™ purchased, the company will provide a complimentary comprehensive eye health examination to one child in need through the Sight for Kids program. Sight for Kids is one of the world’s most influential school-based eye health programs. Jointly launched by Johnson & Johnson Vision and the nonprofit Lions Clubs International Foundation (LCIF), it mobilizes eye care professionals to provide comprehensive eye health examinations to schools in underserved communities. The Abiliti™ overnight orthokeratology contact lenses are expected to launch in the United States in late 2021.

[1] JJV data on file 2021: Myopia Compendium

[2] 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.

[3] 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.

[4] Data on File 2021. Menicon Design History file