Urgent Call to FDA: Fast-Track MiYOSMART & Stellest to Protect Vision of our Children!


Urgent Call to FDA: Fast-Track MiYOSMART & Stellest to Protect Vision of our Children!
The Issue
Every day, countless children across the U.S. wake up with worsening vision. Childhood myopia (nearsightedness) is rising at an alarming rate, with experts predicting that by 2050, more than half the global population will be affected. This isn’t just about stronger prescriptions — high myopia increases lifelong risks of retinal detachment, glaucoma, and even blindness.
For families in the U.S., it’s heartbreaking to watch their children’s eyesight deteriorate while FDA approved treatment options are uncomfortable, invasive and limited to:
- Low-dose atropine eye drops (45–55% efficacy): Can cause stinging, blurry near vision, and light sensitivity, making daily use challenging for kids
- Orthokeratology (Ortho-K) lenses (40–50% efficacy): Worn overnight; risk of corneal infection and thinning, especially without close monitoring
- MiSight contact lenses (41–59% efficacy): Inserting and wearing contact lenses daily is difficult for many young children
While children in US struggle with the above options, children in 30 countries such as Canada, UK, Singapore, Japan, China, India, Australia, Germany, and France have access to two revolutionary, non-invasive solutions that are significantly more effective: MiYOSMART (by HOYA) and Stellest (by EssilorLuxottica) — specially designed eyeglass lenses clinically proven to stop or slow myopia progression by 60–67% in children aged 6 to 16.
These lenses are:
✅ Safe and non-invasive, with no known side effects
✅ Easy for children to wear, just like regular glasses
✅ More effective than atropine, Ortho-K, and MiSight
✅ Backed by strong 8+ years of global clinical trial data
✅ Approved in 30+ countries, protecting children’s vision worldwide
Yet in the U.S., neither is approved. Stellest received FDA Breakthrough Device designation in 2021, but is still awaiting final approval. MiYOSMART is not yet under FDA review. We respectfully call on the FDA, the Department of Health and Human Services, and members of Congress to:
- Leverage existing international clinical trial data
- Expedite review and approval of MiYOSMART and Stellest lenses
- Give U.S. families access to safe, effective, and child-friendly treatments, without further delay
For young children between the ages of 5 and 12, myopia often progresses by nearly 1 diopter per year without interventions, and can continue worsening until at least age 16 or beyond. That’s why FDA approval of MiYOSMART and Stellest is urgently needed. Each year of delay puts thousands of children at risk of high myopia and its lifelong complications.
As parents and advocates, we believe no child should be left behind when proven solutions exist. Let’s give every child the chance to see a clear, healthy future.
🙏 Please sign and share this petition with your friends, family and networks on Whatapps, Facebook, Instagram and other channels. Every signature counts!
991
The Issue
Every day, countless children across the U.S. wake up with worsening vision. Childhood myopia (nearsightedness) is rising at an alarming rate, with experts predicting that by 2050, more than half the global population will be affected. This isn’t just about stronger prescriptions — high myopia increases lifelong risks of retinal detachment, glaucoma, and even blindness.
For families in the U.S., it’s heartbreaking to watch their children’s eyesight deteriorate while FDA approved treatment options are uncomfortable, invasive and limited to:
- Low-dose atropine eye drops (45–55% efficacy): Can cause stinging, blurry near vision, and light sensitivity, making daily use challenging for kids
- Orthokeratology (Ortho-K) lenses (40–50% efficacy): Worn overnight; risk of corneal infection and thinning, especially without close monitoring
- MiSight contact lenses (41–59% efficacy): Inserting and wearing contact lenses daily is difficult for many young children
While children in US struggle with the above options, children in 30 countries such as Canada, UK, Singapore, Japan, China, India, Australia, Germany, and France have access to two revolutionary, non-invasive solutions that are significantly more effective: MiYOSMART (by HOYA) and Stellest (by EssilorLuxottica) — specially designed eyeglass lenses clinically proven to stop or slow myopia progression by 60–67% in children aged 6 to 16.
These lenses are:
✅ Safe and non-invasive, with no known side effects
✅ Easy for children to wear, just like regular glasses
✅ More effective than atropine, Ortho-K, and MiSight
✅ Backed by strong 8+ years of global clinical trial data
✅ Approved in 30+ countries, protecting children’s vision worldwide
Yet in the U.S., neither is approved. Stellest received FDA Breakthrough Device designation in 2021, but is still awaiting final approval. MiYOSMART is not yet under FDA review. We respectfully call on the FDA, the Department of Health and Human Services, and members of Congress to:
- Leverage existing international clinical trial data
- Expedite review and approval of MiYOSMART and Stellest lenses
- Give U.S. families access to safe, effective, and child-friendly treatments, without further delay
For young children between the ages of 5 and 12, myopia often progresses by nearly 1 diopter per year without interventions, and can continue worsening until at least age 16 or beyond. That’s why FDA approval of MiYOSMART and Stellest is urgently needed. Each year of delay puts thousands of children at risk of high myopia and its lifelong complications.
As parents and advocates, we believe no child should be left behind when proven solutions exist. Let’s give every child the chance to see a clear, healthy future.
🙏 Please sign and share this petition with your friends, family and networks on Whatapps, Facebook, Instagram and other channels. Every signature counts!
991
Petition created on June 11, 2025