Urgent Call to Ensure U.S. Children Have Access to an FDA-Approved Low-Dose Atropine Therapy for Pediatric Progressive Myopia

To: The U.S. Food & Drug Administration
From: The Undersigned M.D.s, D.O.s, and O.D.s

Pediatric progressive myopia (PPM) is rising at an alarming rate across the United States. As myopia worsens, the lifetime risks of retinal detachment, myopic maculopathy, glaucoma, and permanent visual impairment increase substantially. Low-dose atropine has emerged as one of the most widely studied, used, and clinically trusted therapies worldwide to slow myopia progression.

In the U.S., children who benefit from low-dose atropine can obtain it only through compounded formulations, as no FDA-approved version exists. This dependence on variable compounding practices leaves American families without the regulated, standardized therapy approved in 28 countries across Europe and the UK.

The STAR Study, the largest randomized, well-controlled clinical trial of low-dose atropine for PPM to date, was a rigorously designed Phase 3 clinical program evaluating a standardized low-dose atropine formulation. It met its pre-specified primary and secondary endpoints, demonstrating:

Clinically meaningful slowing of myopia progression, particularly in younger and faster-progressing children

A favorable safety and tolerability profile suitable for chronic pediatric use

A formulation created specifically for long-term, daily administration

These findings mirror what U.S. eye-care providers observe in clinical practice every day: low-dose atropine can meaningfully slow a child’s rate of myopic progression.

Why an FDA-Approved Low-Dose Atropine Is Urgently Needed

1. Consistency & Quality:  A regulated product ensures standardized concentration, sterility, purity, and stability—features that compounded preparations cannot uniformly guarantee.

2. Equitable Access:  An approved national therapy ensures that children across all geographic and socioeconomic settings—not only those near select compounding pharmacies—can receive treatment.

3. Clear Dosing & Safety Guidance:  FDA labeling provides reliable, evidence-based direction for long-term management of a chronic pediatric condition.

4. Public-Health Impact:  Early intervention reduces the long-term burden of avoidable retinal disease and vision loss.

Our Commitment

As physicians and optometrists, we care for these children every day. We witness the progression, the risks, and the lifelong consequences of inaction. We know the difference early intervention makes.

The science is sound.
The need is urgent.
The time for approval is now.

We, the undersigned, urge the FDA to move forward in making a safe, consistent, well-regulated low-dose atropine therapy available to the millions of U.S. children facing progressive myopia.