On Friday, the U.S. Food and Drug Administration (FDA) announced that it has approved the first contact lens called MiSight, developed by CooperVision, for showing down the progression of myopia (shortsightedness) in children between the ages of 8 and 12.
MiSight is a disposable, single-use soft contact lens that should be discarded after a day’s use. It is not intended to be worn overnight.
It is indicated to correct myopia and slow down its progression children with healthy eyes, the FDA said.
Just like standard corrective lenses used for refractive errors, MiSight corrects myopia. It has concentric peripheral rings that focus part of the light in front of the retina, which helps reduce the stimulus that causes myopia progression.
The agency approved MiSight after considering the findings of a clinical trial. In a three-year randomized clinical trial conducted on 135 children, the safety and efficacy of MiSight were demonstrated.
During the trial period, children who wore MiSight soft contact lenses had less progression of myopia when compared with children who wore conventional contact lenses.
Experts also found that those who wore MiSight lenses had minimal changes in the eyeball’s axial length on yearly checkups. There were no serious ocular side effects reported. The FDA also looked at a retrospective evaluation of medical records of nearly 730 children aged between 8 and 12 years old from seven different community eye care clinics. The agency said the data showed that the children who wore MiSight have a similar rate of corneal ulcer as in adults who wear them daily.
