The U.S. Food and Drug Administration has approved the first contact lens indicated to slow the progression of myopia in children between the ages of 8 and 12 years old.
The FDA granted approval of MiSight, a single-use disposable soft contact lens, to CooperVision Inc.
“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 Dr. Malvina Eydelman, director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices in the FDA’s Center for Devices and Radiological Health.
Myopia is the most frequent cause of correctable visual impairment worldwide, the FDA noted in a press release announcing the approval. It is common in children and tends to increase as they get older.
CooperVision said in its own press release that MiSight is “the cornerstone of a comprehensive myopia management approach” that it will offer.
“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 U.S. and worldwide,” said Daniel G. McBride, president of CooperVision. “Eye care professionals who embrace this breakthrough approach will improve the quality of life and eye health for so many children.”
The product will launch in the U.S. as part of a CooperVision myopia management initiative beginning in March 2020, according to the company’s release. The lens “is already being successfully worn by thousands of myopic children in other parts of the world, including Canada, the United Kingdom, Spain and Australia, where age ranges for initial fitting may vary.”
MiSight “has been recognized as one of the most innovative developments in eye health by the likes of the British Contact Lens Association and international industry media,” according to the release.
The MiSight soft contact lenses are meant to be worn daily to correct nearsightedness and slow the progression of myopia in children with healthy eyes. When placed on the eye, one part of the MiSight contact lens corrects the refractive error to improve distance vision in nearsighted eyes, similar to a standard corrective lens. In addition, concentric peripheral rings in the lens focus part of the light in front of the retina (the back of the eye). This is believed to reduce the stimulus causing the progression of myopia.
The approval of MiSight was based on data obtained from a prospective clinical trial at four clinical sites and real-world evidence. The safety and effectiveness of MiSight was studied in a three-year randomized, controlled clinical trial of 135 children ages 8 to 12 at the start of treatment who used MiSight or a conventional soft contact lens.
The trial showed that for the full three-year period, the progression in myopia of those wearing MiSight lenses was less than those wearing conventional soft contact lenses. In addition, subjects who used MiSight had less change in the axial length of the eyeball at each annual checkup. Over the course of the trial, there were no serious ocular adverse events in either arm of the study.
Additionally, to estimate the rate of vision-threatening corneal infections among children and adolescents who wear soft contact lenses daily, the FDA reviewed real world data from a retrospective analysis of medical records of 782 children ages 8 to 12 years old from seven community eyecare clinics. The results showed a rate comparable to the rate of ulcer cases among adults who wear contact lenses daily.
As part of the approval of MiSight, the sponsor is required to conduct a postmarket study of the contact lenses to further evaluate the safety and effectiveness of the product as indicated.