July 2026
The FDA recently announced it intends to convene an Advisory Committee meeting to review SYD-101, an investigational low-dose atropine ophthalmic solution being evaluated for the treatment of progressive pediatric myopia (PPM). If ultimately approved, SYD-101 would become the first FDA-approved pharmaceutical treatment for PPM in the United States.
Until that time, there remains no FDA-approved pharmaceutical treatment for progressive pediatric myopia in the U.S. As noted in recent coverage by Optometry Times, many eye care providers continue to prescribe compounded low-dose atropine as part of their myopia management strategy while awaiting an approved product.
Progressive myopia is an increasing public health concern, with children developing myopia at younger ages and facing a greater lifetime risk of vision-threatening complications associated with high myopia, including retinal detachment, glaucoma, cataracts, and myopic maculopathy. Because the greatest rate of progression often occurs in younger children, early intervention remains an important consideration for many clinicians.
Current Status
- No FDA-approved pharmaceutical treatment for progressive pediatric myopia in the U.S.
- FDA plans to convene an Advisory Committee to review SYD-101.
- Many clinicians continue to prescribe compounded low-dose atropine while awaiting an approved option.
At Massey Drugs, we compound Preservative-Free Atropine Sulfate Ophthalmic Solution in the following concentrations:
- 0.01%
- 0.025%
- 0.05%
Our sterile ophthalmic preparations are compounded in our NABP-accredited compounding pharmacy and prepared pursuant to a valid prescription for an individual patient.
We’ll continue to monitor developments in the FDA review process and look forward to sharing updates as they become available. If you have questions about our preservative-free atropine formulations or would like prescribing information, contact us at 833.540.3500.
Important: Compounded medications are not FDA-approved and are not reviewed by the FDA for safety, effectiveness, manufacturing consistency, or labeling. They are prepared only in response to a valid patient-specific prescription when a prescriber determines a compounded medication is appropriate.