New FDA approval expands access to myopia management

Johnson & Johnson Vision receives FDA-approval of lens parameter expansion for their ACUVUE Abiliti Overnight Therapeutic Lenses for Myopia Management.

Johnson & Johnson Vision (JJV) today announced FDA approval of an expanded range of ACUVUE® Abiliti™ Overnight Therapeutic Lenses for Myopia Management, now up to 6.00 diopters (previously 4.00 diopters). JJV also announced greater availability of the lenses nationwide at Vision By Design 2022, an annual myopia control and management meeting taking place September 28 – October 2 in Bellevue, Washington.

Key highlights:

  • ACUVUE® Abiliti™ Overnight Therapeutic Lenses for Myopia Management expands access to more patients with FDA approval of lens parameter expansion and greater availability in North America
  • FitAbiliti™ software delivers first fit success rate of approximately 90%*1
  • JJV reveals expansion and evidence-based myopia management strategies at Vision By Design 2022

“By expanding the parameters for Abiliti™ Overnight lenses, it creates more opportunities for eye care professionals to reach even more patients,” said Chandra Mickles, OD, MS, FAAO, FSLS, North America Professional Education Lead, Myopia, Johnson & Johnson Vision.

“The expansion of treatment options comes at a critical time as myopia rates continue to rise among children.2 At Johnson & Johnson Vision, we remain committed to changing the trajectory of myopia with evidence-based strategies and professional support.”

Myopia, also called ‘nearsightedness’, is a chronic and progressive disease that poses the biggest eye health threat of the 21st Century.2-5 Children under 12 who are diagnosed with myopia are at greater risk of developing high myopia which may lead to sight threatening complications later in life.6

Abiliti™ Overnight lenses are orthokeratology (ortho-k) lenses and are worn overnight to temporarily reduce refractive error and subject to an eye care professional’s myopia management plan, mayeliminate the need to wear contact lenses or glasses during waking hours after the lenses are removed.**7

The lenses are designed to match a patient’s eye based on its unique corneal shape and prescription. The FitAbiliti™ software guides the eye care professional through the fitting process empirically and recommends a lens with the first fit success rate of approximately 90%.*1

“Myopia is on the rise and it is critical to meet increasing patient needs with innovative solutions,”2 said Nicholas Despotidis, OD, FAAO, FCOVD, FAAOMC. “With this new expansion of Abiliti™ Overnight lenses, optometrists are now able to provide additional treatment options to even more myopic patients. Getting the fitting right as efficiently as possible is important and I’ve found great success and ease-of-use with the FitAbiliti™ software.”

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 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.

Abiliti™ Overnight Therapeutic Lenses for Myopia Management are now available nationwide. The lenses are available in two different lens designs: ACUVUE® Abiliti™ Overnight Therapeutic Lenses for Myopia Management and ACUVUE® Abiliti™ Overnight Therapeutic Lenses for Myopia Management for Astigmatism.7

Patients and eye care professionals seeking more information can visit: www.seeyourabiliti.com.

**For the purposes of refractive correction, the lenses are indicated for reducing error up to 6.00D of myopia and up to 1.50D of astigmatism. Results may vary by patient and prescription level.
*Final lens fit is determined by the ECP - software is for decision support only
REFERENCES
  1. JJV Data on File 2022. ACUVUE Abiliti Overnight Therapeutic Lenses for Myopia Management - Consolidated, Approved Claims List; U.S. Only Claims
  2. Pärssinen O, Kauppinen M. Risk factors for high myopia: a 22-year follow-up study from childhood to adulthood. Acta Ophthalmologica. 2019;97(5):510-518.
  3. Flitcroft DI et al. IMI–Defining and classifying myopia: a proposed set of standards for clinical and epidemiologic studies. Invest Ophthalmol Vis Sci. 2019;60:M20-30.
  4. Donovan L, Sankaridurg P, Ho A et al. Myopia progression rates in urban children wearing single-vision spectacles. OVS 2012;89(1):27-32.
  5. Holy C, Kulkarni K, Brennan NA. Predicting Costs and Disability from the Myopia Epidemic – A Worldwide Economic and Social Model. Invest Ophthalmol Vis Sci.2019;60(9):5466-5466.
  6. 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.
  7. Data on File 2022. Instruction for Use.
  8. Data on File 2021. Menicon Design History File.