CooperVision has received clearance from the US Food and Drug Administration (FDA) for its MiSight 1 Day Contact Lens for Childhood Myopia.
After passing the organisation’s stringent premarket approval pathway, the lens is now the only product clinically approved by the FDA to slow the progression of myopia in children.
“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 US and worldwide,” Mr Daniel McBride, president of CooperVision, said.
“Eye care professionals who embrace this breakthrough approach will improve the quality of life and eye health for so many children.”
The approval comes after several years of research, including a prospective, multi-centre, double masked randomised multi-year study of 144 myopic children aged from 8 to 12 years.
The results, which were published in the journal Optometry and Vision Sciences last August, demonstrated that the MiSight lenses successfully slowed myopia progression by 59% for mean cycloplegic spherical equivalent and 52% as measured by mean axial elongation of the eye.
In a statement announcing the approval, the FDA cited the positive results of this trial, as well a rate of corneal infections in line with expectations, as the main evidence supporting their decision.
“The time and effort we put into receiving FDA approval was well-spent,” Mr Jerry Warner, executive vice president of Coopervision’s Americas and global commercial functions, said.
“We’re bringing a game-changing myopia management approach to US eye care professionals that will benefit countless kids throughout the country.”
CooperVision is also be required to conduct a postmarket study to further evaluate the lens’ effectiveness and safety.
It will launch in the US in March 2020 as part of a broader myopia management initiative being organised by CooperVision. The lens is already in use throughout Canada, the United Kingdom, Spain and Australia.
