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Inducement and Evaluation of a Murine Model of Experimental Myopia
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Compounding of Low-Concentration Atropine for Myopia Control
Kathryn Richdale1, Erin S Tomiyama, Gary D Novack
1University of Houston (K.R., E.T., M.A.B.), College of Optometry, Houston, TX; PharmaLogic Development, Inc (G.D.N.), San Rafael, CA; and Department of Ophthalmology & Vision Sciences (G.D.N.), School of Medicine, University of California, Davis, CA.
Eye & Contact Lens
|September 9, 2022
Summary
Compounding pharmacies show varied methods for preparing and labeling low-concentration atropine eye drops for myopia control. These differences in formulation, storage, and expiration dates may impact treatment efficacy and safety.
Area of Science:
- Ophthalmology
- Pharmacology
- Pediatric Eye Care
Background:
- Low-concentration atropine is a common treatment for slowing myopia progression in children.
- It is not FDA-approved for this use and is primarily available from compounding pharmacies in the US.
Purpose of the Study:
- To investigate the compounding and labeling practices for low-concentration atropine in the United States.
- To identify variations in preparation, storage, and beyond-use dating among compounding pharmacies.
Main Methods:
- A survey was conducted targeting US compounding pharmacies identified through various professional and online channels.
- Twenty-eight pharmacies were contacted, and 26 provided responses to a standardized set of questions regarding their compounding and labeling procedures.
Main Results:
- Significant variability was observed in bottle sizes (median 5 mL), storage recommendations (refrigeration vs. room temperature), and beyond-use dates (median 65 days).
- Preparation methods differed, with 50% using commercial 1% atropine solution and 38% using powdered atropine.
- Excipient use varied, with 42% using artificial tears only and 23% using saline only.
Conclusions:
- Wide variations in formulation, storage, and expiration dating exist among US compounding pharmacies for low-concentration atropine.
- These inconsistencies may influence the stability and potency of the compounded atropine.
- Further research is necessary to understand the impact of these variations on the efficacy and safety of myopia control treatments.
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