Soft contact lens manufacturer CooperVision has secured approval for its MiSight contact lens from the US Food and Drug Administration (FDA) to slow the progression of myopia (nearsightedness) in children aged between 8 and 12 years old at the initiation of treatment.

Manufactured as a single use, disposable, soft contact lens, the MiSight contact lens are to be thrown away after the end of each day, and should not be worn overnight.

Malvina Eydelman – director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices in the FDA Center for Devices and Radiological Health said: “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.”

According to the FDA, the MiSight soft contact lenses should be daily worn to correct nearsightedness and slow the progression of myopia in children having healthy eyes. When inserted on the eye, a part of the MiSight contact lens corrects the refractive error to improve distance vision in nearsighted eyes, which is almost same as a standard corrective lens.

Additionally, concentric peripheral rings in the lens focus part of the light in front of the retina. The FDA says that this is thought to reduce the stimulus that aids in the progression of myopia.

The approval of MiSight contact lens was driven by the data collected from a prospective clinical trial held at four clinical sites and real-world evidence. The safety and effectiveness of the contract lens was assessed in a three-year randomized, controlled clinical trial featuring 135 children aged 8 to 12 at the start of treatment who used the CooperVision lens or a conventional soft contact lens.

The trial demonstrated that for the full three-year period, the progression in myopia of those wearing MiSight lenses was less compared to those who put conventional soft contact lenses. Apart from that, children who used the MiSight lenses had less change in the axial length of the eyeball at each yearly checkup.

During the course of the trial, there weren’t any serious ocular adverse incidents in either arm of the study.

The FDA also looked into the real world data from a retrospective analysis of medical records of 782 children, aged 8 to 12 years old across seven community eye care clinics. This was to assess the rate of vision-threatening corneal infections among children and adolescents who daily wear soft contact lenses.

The results proved a rate comparable to the rate of ulcer cases in adults who daily wear contact lenses.

CooperVision needs to carry out a postmarket study of the contact lenses to further assess the safety and effectiveness of the product as indicated, said the FDA.

As part of the approval of MiSight, the sponsor is required to conduct a postmarket study of the MiSight contact lens to further evaluate the safety and effectiveness of the product as indicated.

  CooperVision, FDA, Malvina Eydelman, MiSight contact lens, myopia, US Food and Drug Administration, USA