I have two young kids who are under 5 years old, and regular trips to the pediatrician are certainly part of our busy schedule. And I love it!
I love observing other physicians and their practice’s staff work—from the eyes of a patient. It’s a fun perspective and is a frank reminder of the mixture of emotions that a parent goes through when taking their child to any medical appointment.
Naturally, when the pediatrician asks me what work I do, I’m not shy, and launch into a spiel about how myopia is a huge problem affecting children globally. She’s certainly become a referral source for our office, and her kids are patients in our myopia management program as well!
I have told her about all the new technology that is coming down the pipeline to treat children’s myopia. Eventually, the conversation turns to the U.S. Food and Drug Administration’s (FDA’s) role in regulating treatments such as new soft multifocal contact lenses, orthokeratology lens designs, spectacle lenses, and atropine eye drops.
Her response was interesting: “FDA approval? Why are some eye-care professionals waiting for FDA approval for these things before helping the children out? Eighty percent of what I prescribe here on a regular basis has no FDA approval.”
She’s correct that the majority of drugs prescribed to children in the United States are not FDA-approved (Camark et al, 2020). The extra cost and study designs needed to get past all the regulatory hurdles for FDA approval of a drug for pediatric use are tremendous. However, she is happy to still practice at the standard of care, regardless of FDA approval. Any panel of her peers would bless her work and tell her to stay the course.
The Way Things Are
In pediatric eye care, our experience is similiar to hers. Despite not having FDA approval, our office has been prescribing (off-label) orthokeratology, atropine, and soft multifocal contact lenses for many years. This has been good for patients, and we’ve helped more than 1,000 kids lead healthier lives because of it. The clinical research and safety and efficacy literature supports our stance, as well.
In some sense, we are luckier than many pediatricians. Most of the drugs that they prescribe will never attain FDA approval for pediatric populations. However, FDA approval for optical devices that are indicated for myopia control or management is already a reality. We have FDA-approved soft multifocal contact lenses. We have FDA approval for an overnight orthokeratology lens design. Atropine is currently in clinical trials ultimately intended to be used for regulatory approvals. So despite the extra cost and testing required, we have to applaud the eyecare industry—which has gone through more costly testing and sought-after FDA-approval to elevate our mission to help children all over the world have better vision.
While years ago myopia management was considered an uncommon eyecare specialty, it is now becoming mainstream. I believe it will resemble our treatment of glaucoma. We will identify progressive myopia as an ocular disease worth treating, above and beyond simple refractive error. Treating little eyes has becoming the next big thing in eye care. CLS
- Camark M, Hwang T, Bourgeois F. Pediatric Drug Policies Supporting Safe And Effective Use Of Therapeutics In Children: A Systematic Analysis. Health Aff (Millwood). 2020 Oct;39:1799-1805.