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Thursday / June 24.
HomeminewsMyopia Management Overnight CLs FDA Approved

Myopia Management Overnight CLs FDA Approved

In a world first, an orthokeratology (OK) contact lens (CL) for myopia management has been approved by the Federal Drug Administration (FDA).

Johnson & Johnson Vision’s Abiliti Overnight CL is available in sphere and toric designs to correct various combinations of corneal shapes and refractive errors.

“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 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, a chronic and progressive disease, poses the biggest eye health threat of the 21st Century.1 Children younger than 12 years of age that become myopic are the most vulnerable to develop high myopia and can be at increased risk of sight-threatening eye diseases later in life.2 Additionally, half of the world’s population is projected to be myopic by 2050 with nearly one billion people expected to have high myopia.3

Abiliti Overnight will be available in two different CL designs: Abiliti Overnight Therapeutic Lenses, and Abiliti Overnight Therapeutic Lenses for Astigmatism

Clinical studies have demonstrated that OK lenses can be a safe and effective treatment option to manage myopia.4,5,6,7 Abiliti Overnight OK CLs are specifically designed and fitted to match the eye, based on its unique corneal shape to temporarily reshape the cornea.8 Abiliti Overnight will be available in two different CL designs: Abiliti Overnight Therapeutic Lenses, and Abiliti Overnight Therapeutic Lenses for Astigmatism.

Software Optimised

The CLs are optimised 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 Abiliti Overnight will provide eye care professionals and parents with more options to manage myopia.”

Building on Myopia Firsts

Earlier this year, Johnson & Johnson Vision 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.

Giving Back

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

*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.

†† Compared to single vision spectacles

  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

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