The Food and Drug Administration (FDA) has approved MiSight contact lens, the first contact lens 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 to 12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤0.75 diopters of astigmatism.
The MiSight lenses were developed and will be marketed by CooperVision. The single use, disposable, soft contact lens is intended to be discarded at the end of the day. One part of the MiSight contact lens corrects the refractive error to improve distance vision in nearsighted eyes, while concentric peripheral rings in the lens focus part of the light in front of the retina, which is believed to reduce the stimulus causing myopia progression.
The approval was based on a 3-year randomized, controlled trial involving 135 children aged 8 to 12 years. Results showed that unadjusted change in spherical equivalent refraction was -0.73 D (59%) less in the MiSight group than in the group using conventional soft contact lenses (-0.51 ± 0.64 vs -1.24 ± 0.61 D, P <.001), while the mean change in axial length was 0.32mm (52%) less in the MiSight group than in the conventional soft contact lens group (0.30 ± 0.27 vs. 0.62 ± 0.30mm, P <.001). No serious adverse events occurred during the study.
The MiSight 1 day lenses are expected to be available in the US in March 2020.
“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 in the FDA’s Center for Devices and Radiological Health.
For more information visit coopervision.com.