FDA NewsPerspective

FDA approves MiSight contact lens to slow myopia progression in children

The first contact lens indicated to slow myopia progression in children aged 8 to 12 years has received FDA approval, according to an FDA press release.

The MiSight contact lens (CooperVision) is a disposable, soft lens that is limited for one-time use and is not for wearing overnight, the release stated.

The effectiveness and safety of the lens was tested during a 3-year randomized controlled clinical study consisting of 135 children aged 8 to 12 years compared with a conventional soft contact lens. The results of the study showed that myopia was decreased with the MiSight lens compared with a conventional lens.

“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,” Malvina Eydelman, MD, director of the division of ophthalmic, and ear, nose and throat devices in the FDA’s Center for Devices and Radiological Health, said in the release.

The first contact lens indicated to slow myopia progression in children aged 8 to 12 years has received FDA approval, according to an FDA press release.

The MiSight contact lens (CooperVision) is a disposable, soft lens that is limited for one-time use and is not for wearing overnight, the release stated.

The effectiveness and safety of the lens was tested during a 3-year randomized controlled clinical study consisting of 135 children aged 8 to 12 years compared with a conventional soft contact lens. The results of the study showed that myopia was decreased with the MiSight lens compared with a conventional lens.

“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,” Malvina Eydelman, MD, director of the division of ophthalmic, and ear, nose and throat devices in the FDA’s Center for Devices and Radiological Health, said in the release.

    Perspective
    Courtney Kraus

    Courtney Kraus

    The FDA recently approved the use of the MiSight contact lens (CooperVision) to slow myopia progression in children. The safety and effectiveness were based off of a recent study published in the journal Optometry and Vision Science analyzing 135 children aged 8 to 12 years randomly assigned to a daily-wear MiSight lens vs. standard daily disposables for 3 years. Of note, there was no comparison group using dilute atropine, the preferred agent for myopia control for many pediatric ophthalmologists.

    The lenses themselves work by inducing peripheral myopic defocus, a concept thought to prevent myopic progression by recent research. The contacts have a central zone of full myopic power and peripheral plus “rings” to defocus. They are worn like standard contact lenses, not overnight as in orthokeratology.

    The authors reported that the contacts were well tolerated. The study group had –0.75 D less myopic progression and 0.3 mm less axial length elongation compared with the control group. This is somewhat comparable to the effect of dilute atropine in the ATOM2 study. An important note is they included no washout period in which the study group was placed in standard contact lenses to see if the treatment effect could be maintained.

    Serious adverse events were not reported, but four corneal infiltrates were observed. This was in both control and study groups.

    Parents and pediatric ophthalmologists alike are actively looking for the best method to prevent myopia progression. Currently, in my own practice, I use dilute atropine and have done so with success and no serious issues and will likely continue despite the FDA’s recent actions. However, for those tweens and teens already demonstrating the responsibility and cleanliness it takes to be a contact lens wearer, the MiSight contact lens may be an interesting alternative. I look forward to more longitudinal data to help guide whether to incorporate this into my practice.

    • Courtney Kraus, MD
    • OSN Pediatrics/Strabismus Board Member

    Disclosures: Kraus reports no relevant financial disclosures.