J&J Vision ACUVUE Abiliti Overnight Lenses for Myopia Earn FDA Approval

Johnson & Johnson Vision received U.S. Food and Drug Administration (FDA) approval for its ACUVUE Abiliti Overnight Therapeutic Lenses, the first and only FDA approved orthokeratology (ortho-k) contact lens for myopia management, according to the company. 
 
“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,” Xiao-Yu Song, MD, PhD, Global Head of Research & Development, Johnson & Johnson Vision told the press. “We look forward to supporting parents and eye care 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.”
 
Myopia is a chronic and progressive disease that poses the biggest eye health threat of the 21st Century¹. Young children less than 12 years of age and become myopic are the most vulnerable to develop high myopia and may have 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 almost one billion expected to have high myopia³.
 
Clinical studies demonstrated ortho-k lenses can be a safe, effective treatment option to manage myopia^4,5,6,7. Abiliti Overnight ortho-k contact lenses match the eye based on unique corneal shape to temporarily reshape the cornea⁸. Abiliti Overnight will be available in two different designs: Abiliti Overnight Therapeutic Lenses, and Abiliti Overnight Therapeutic Lenses for Astigmatism.
 
Abiliti Overnight contact lenses are optimized by corneal topography, refractive error, and other measurements connected to fitting software—a sophisticated, user-friendly tool that provides a precise corneal shape measure and accurately guides the fitting process for consistent and successful first fit rates of approximately 90 percent, according to the company.
 
“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 care professionals and parents with more options to manage 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.
 
References
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 Liu, YM, Peiying, X. The Safety of Orthokeratology—A Systematic Review. Eye Contact Lens. 2016;42(1):35-42. doi: 10.1097/ICL.0000000000000219.
⁵ Cho P, Cheung SW. Retardation of Myopia in Orthokeratology (ROMIO) Study: a 2-year Randomized Clinical Trial. Invest Ophthalmol Vis Sci. 2012;53(11):7077–85. doi: 10.1167/iovs.12-10565.
⁶ Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutiérrez-Ortega R. Myopia Control with Orthokeratology Contact Lenses in Spain: Refractive and Biometric Changes. Investig Ophthalmol Vis Sci. 2012;53(8).5060-5. doi: 10.1167/iovs.11-8005.
⁷ Chen C, Cheung SW, Cho P. Myopia Control Using Toric Orthokeratology (TO-SEE study). Invest Ophthalmol Vis Sci. 2013;54(10):6510–7. doi: 10.1167/iovs.13-12527.
⁸ Data on File 2021. Menicon Design History file