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Atropine Sulfate 0.04% Eye Drop
Atropine blocks muscarinic acetylcholine receptors in the eye to dilate the pupil and paralyze accommodation.
Atropine blocks muscarinic acetylcholine receptors in the eye to dilate the pupil and paralyze accommodation. Used for Mydriasis and cycloplegia for diagnostic purposes, Myopia control in children (off-label/emerging indication).
At a glance
| Generic name | Atropine Sulfate 0.04% Eye Drop |
|---|---|
| Sponsor | Shanghai Eye Disease Prevention and Treatment Center |
| Drug class | Anticholinergic agent / Muscarinic receptor antagonist |
| Target | Muscarinic acetylcholine receptors (M1, M3, M5) |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | FDA-approved |
Mechanism of action
Atropine is an anticholinergic agent that competitively antagonizes muscarinic receptors on the iris sphincter muscle and ciliary muscle. This prevents acetylcholine-mediated contraction, resulting in mydriasis (pupil dilation) and cycloplegia (paralysis of accommodation). In the context of myopia control, atropine may work by relaxing accommodation-induced ciliary muscle tension and potentially altering scleral remodeling.
Approved indications
- Mydriasis and cycloplegia for diagnostic purposes
- Myopia control in children (off-label/emerging indication)
Common side effects
- Mydriasis (pupil dilation)
- Cycloplegia (accommodation paralysis)
- Photophobia
- Blurred vision
- Local irritation or hyperemia
- Systemic anticholinergic effects (rare with topical use)
Key clinical trials
- Low Concentration Atropine Combined With Soft Contact Lens in Controlling Myopia Progression in Children With High Myopia (PHASE4)
- Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control (PHASE1, PHASE2)
- Auricular Acupressure Reduces Rebound Effects After Discontinuation of Atropine (NA)
- The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression (PHASE3)
- Low Concentration Atropine in the Prevention of Myopia in Children. (NA)
- Myopia Intervention in Children and Adolescents and Establishment of a Precise Intervention Model (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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