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 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ISOPTO ATROPINE (Atropine Sulfate) is a topical ophthalmic solution that acts as a muscarinic acetylcholine receptor antagonist. It induces mydriasis by blocking acetylcholine-mediated pupillary sphincter contraction and cycloplegia by paralysing the ciliary muscle, enabling diagnostic and therapeutic eye procedures. It is used for cycloplegic refraction, pupil dilation, and management of accommodative esotropia.
$0.063BPart D
PeakStable
The product is in peak lifecycle stage with modest Medicare utilization (984 claims annually), indicating a stable, niche-market ophthalmic franchise requiring focused commercial execution.
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
Worked on ISOPTO ATROPINE at Alcon? Share your interview experience or compensation data (+7 days Pro)
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.