The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > 2019 > 11 > FDA Approves Contact that Slows Nearsightedness Progression

FDA Approves Contact that Slows Nearsightedness Progression

Posted 18 November 2019 | By Michael Mezher 

FDA Approves Contact that Slows Nearsightedness Progression

The US Food and Drug Administration (FDA) on Friday granted premarket approval (PMA) to CooperVision’s MiSight contact lens to slow the progression of myopia, commonly known as nearsightedness, in children ages 8-12.
This 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, director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices within the Center for Devices and Radiological Health.
The MiSight lenses are single use, disposable lenses that are not meant to be worn overnight. The company says the lenses will launch in the US in March 2020, and have already launched in the UK, Canada, Spain and Australia.
According to FDA the lenses function similar to other corrective lenses to address nearsightedness, but feature concentric peripheral rings in the lens that “focus part of the light in front of the retina,” which “is believed to reduce the stimulus causing the progression of myopia.”
CooperVision studied the MiSight lenses in a three-year randomized controlled clinical trial that enrolled 144 children with nearsightedness in Singapore, Canada, the UK and Portugal. According to CooperVision, the study found the lenses slowed myopia progression “59% as measured by mean cycloplegic spherical equivalent (SE) and 52% as measured by mean axial elongation of the eye.”
The agency notes there were no serious adverse events in either arm of the study.
FDA also says it reviewed real world data from the medical records of 782 children ages 8-12 to estimate the rate of vision-threatening corneal infections, such as corneal ulcers, among children who wear soft contact lenses daily. FDA says the rate was comparable to the rate among contact-wearing adults.
FDA, CooperVision

Regulatory Focus newsletters

All the biggest regulatory news and happenings.