The FDA approved the first contact lens indicated to slow the progression of myopia in children between the ages of 8 and 12 years old at the initiation of treatment. The MiSight contact lens made by CooperVision is a single use, disposable, soft contact lens that is discarded at the end of each day, and is not intended to be worn overnight.
“Today’s approval is the first FDA-approved product to slow the progression of myopia in children, which ultimately could mean a reduced risk of developing other eye problems,” Malvina Eydelman, MD, director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices in the FDA’s Center for Devices and Radiological Health, said in a news release.
Myopia is common in children and tends to increase as they get older. If a person develops severe myopia as a child, they may be susceptible to other eye problems such as early cataracts or a detached retina during adulthood. The MiSight soft contact lenses are meant to be worn daily to correct nearsightedness and slow the progression of myopia in children with healthy eyes. When placed on the eye, one part of the MiSight contact lens corrects the refractive error to improve distance vision in nearsighted eyes, similar to a standard corrective lens. In addition, concentric peripheral rings in the lens focus part of the light in front of the retina (the back of the eye). This is believed to reduce the stimulus causing the progression of myopia.
“We can’t overstate the importance and potential impact of this landmark decision on children’s vision, especially considering the rise in myopia’s severity and prevalence in the U.S. and worldwide,” Daniel G. McBride, President of CooperVision, said in a company news release. “Eye care professionals who embrace this breakthrough approach will improve the quality of life and eye health for so many children.”
The approval of MiSight was based on data obtained from a prospective clinical trial at four clinical sites and real-world evidence. The safety and effectiveness of MiSight was studied in a 3-year randomized, controlled clinical trial of 135 children ages 8 to 12 at the start of treatment who used MiSight or a conventional soft contact lens. The trial showed that for the full 3-year period, the progression in myopia of those wearing MiSight lenses was less than those wearing conventional soft contact lenses. In addition, subjects who used MiSight had less change in the axial length of the eyeball at each annual checkup. Over the course of the trial, there were no serious ocular adverse events in either arm of the study.
Three-year peer-reviewed results published in Optometry and Vision Science in August 2019 indicated that use of MiSight 1 day was shown to slow myopia progression 59% as measured by mean cycloplegic spherical equivalent (SE), and 52% as measured by mean axial elongation of the eye.*
Additionally, to estimate the rate of vision-threatening corneal infections (i.e., corneal ulcers) among children and adolescents who wear soft contact lenses daily, the FDA reviewed real world data from a retrospective analysis of medical records of 782 children ages 8 to 12 years old from seven community eye care clinics. The results showed a rate comparable to the rate of ulcer cases among adults who wear contact lenses daily.
As part of the approval of MiSight, the sponsor is required to conduct a postmarket study of the contact lenses to further evaluate the safety and effectiveness of the product as indicated.Generally, myopia first occurs in school-age children and progresses until about age 20.2 According to a study published in Clinical Ophthalmology in August 2018, 41.9% of U.S. children ages 5-19 are myopic.9 This is due in part to changing lifestyles, with children spending less time outdoors and more time spent focusing on close objects such as digital screens.
MiSight 1 day will launch in the United States as part of a CooperVision myopia management initiative beginning in March 2020. The lens is already being worn by thousands of myopic children in other parts of the world, including Canada, the United Kingdom, Spain and Australia, where age ranges for initial fitting may vary.
1 MiSight® (omafilcon A) daily wear single use Soft Contact Lenses are indicated for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤ 0.75 diopters of astigmatism. The lens is to be discarded after each removal.
2 What You Should Know if Your Child is Nearsighted (Infographic). Retrieved October 29, 2019 from: https://www.allaboutvision.com/parents/myopia-facts-infographic.htm
3 Macular Society. Myopia, Pathological Myopia and Myopic Macular Degeneration. Retrieved October 29, 2019 from: https://www.macularsociety.org/sites/default/files/resource/Macular%20Society%20Factsheet%20-%20Myopic%20Macular%20Degeneration%202017%20-%20ACCESS.pdf