NDAOPHTHALMICSOLUTION/DROPS
Approved
Dec 2016
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
6/8 — Strong
ISOPTO ATROPINE (atropine sulfate) by Alcon is (and sympathetic) acetylcholine muscarinic receptors. Approved for myopia. First approved in 2016.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ISOPTO ATROPINE (atropine sulfate) is a topical ophthalmic solution that treats myopia by blocking muscarinic acetylcholine receptors on the eye. It works by inducing mydriasis (pupil dilation) and cycloplegia (paralysis of the ciliary muscle), preventing accommodation and pupillary constriction. This mechanism allows the radial dilator muscle to contract unopposed, resulting in sustained mydriasis.
$0.063MPart D
PeakProduct is at peak commercial stage with modest Part D spending ($63K); team size likely stable with focus on maintaining market position against generic competition.
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 (1)
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
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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.