Children with nearsightedness (myopia) may now benefit from the first contact lens approved by FDA for slowing the progression of the common condition.
Until now, traditional eyeglasses and contact lenses available in the United States have only been developed to correct blurred vision (a symptom of myopia), but not for slowing the progression of the condition.
“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,” said Malvina Eydelman, MD, director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices at FDA’s Center for Devices and Radiological Health.
The MiSight contact lens from San Ramon, CA-based CooperVision is a single-use, disposable soft contact lens that is intended to be discarded and the end of each day and not worn overnight. The lens is designed to correct nearsightedness and slow the progression of myopia in children with healthy eyes.
“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," said Daniel McBride, president of CooperVision. "Eye care professionals who embrace this breakthrough approach will improve the quality of life and eye health for so many children.”
Myopia occurs when the eye grows too long from front to back (axial length). Instead of focusing images on the retina, images are focused at a point in front of the retina. As a result, people with myopia have good near vision, but poor distance vision that can be corrected with glasses or contact lenses. The condition tends to get worse as children get older. People who have severe myopia as a child may be susceptible to things like early cataracts, glaucoma, or a detached retina during adulthood.
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.
FDA said 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 three-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 three-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, the agency noted.
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.
FDA is requiring CooperVision to conduct a postmarket study of the contact lenses to further evaluate the product's safety and effectiveness.