MiSight is a single use, disposable and soft contact lens that must be discarded at the end of each day
CooperVision has secured approval from the US Food and Drug Administration (FDA) for its MiSight contact lens to delay the progression of myopia in children.
The contact lens has been developed to slow the progression of myopia in children between the ages of 8 and 12 years old at the initiation of treatment.
MiSight is a single use, disposable, soft contact lens, which should be discarded at the end of each day and cannot be worn overnight.
The FDA’s Center for Devices and Radiological Health’s ophthalmic, anesthesia, respiratory, ENT and dental devices director Dr Malvina Eydelman 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.”
Myopia, which is a major reason for correctable visual impairment across the world, occurs when the eye grows too long from front to back (axial length).
MiSight soft contact lens corrects refractive error
Similar to a standard corrective lens, one part of the MiSight contact lens corrects the refractive error to enhance distance vision in nearsighted eyes when placed on the eye.
The approval for the contact lens was based on data from a clinical trial at four clinical sites and real-world evidence.
Its safety and effectiveness was evaluated in a three-year randomised and controlled clinical trial of 135 children aged between 8 and 12 at the start of treatment who used MiSight or a conventional soft contact lens.
The study demonstrated that for the full three-year period the progression in the myopia of those wearing MiSight lenses was less than those wearing conventional soft contact lenses, said the regulator.
The sponsor needs to carry out a postmarket study of MiSight contact lenses to further assess the safety and effectiveness of the product as indicated, as part of the approval.