NDAOPHTHALMICSOLUTION/DROPS
Approved
Dec 2016
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
5/8 — Partial
ISOPTO ATROPINE (atropine sulfate) by Alcon is (and sympathetic) acetylcholine muscarinic receptors. First approved in 2016.
Drug data last refreshed 9m ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ISOPTO ATROPINE is a topical ophthalmic solution containing atropine sulfate, a muscarinic acetylcholine receptor antagonist. It is indicated for mydriasis (pupil dilation) and cycloplegia (paralysis of accommodation) in diagnostic and therapeutic eye procedures. The drug works by blocking acetylcholine at the eye's sphincter and ciliary muscles, preventing their contraction and allowing opposing muscles to dilate the pupil and relax accommodation.
$0.063BPart D
PeakStable
Product is at peak lifecycle stage with modest Part D utilization, suggesting a stable mature franchise with limited growth opportunity and likely focused maintenance-mode commercial teams.
Mechanism of Action
(and sympathetic) acetylcholine muscarinic receptors. Topical atropine on the eye induces mydriasis by inhibiting contraction of the circular pupillary sphincter muscle normally stimulated by acetylcholine. This inhibition allows the countering radial pupillary dilator muscle to contract which…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
A Study of Atropine Sulfate in Healthy Chinese Volunteers
Started May 2023
30 enrolled
Pharmacokinetics
A Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops
Started May 2022
526 enrolled
Myopia
A Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops
Started Mar 2022
777 enrolled
Myopia
Career Relevance
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.