ISOPTO ATROPINE (atropine sulfate)
Isopto Atropine is an ophthalmic solution used to dilate the pupil and temporarily paralyze the eye's focusing muscles. It helps patients who require these effects for eye examinations or specific ocular conditions. Additionally, it treats amblyopia by blurring the vision in a patient's healthy eye to encourage the use of the weaker eye.
How ISOPTO ATROPINE Works
This medication works by blocking acetylcholine from binding to muscarinic receptors in the eye. This action prevents the pupillary sphincter muscle from contracting, allowing the pupil to dilate, while also paralyzing the ciliary muscle to stop the eye from focusing on objects.
Details
- Status
- Prescription
- First Approved
- 2016-12-01
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
ISOPTO ATROPINE Approval History
What ISOPTO ATROPINE Treats
3 indicationsISOPTO ATROPINE is approved for 3 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Mydriasis
- Cycloplegia
- Amblyopia
ISOPTO ATROPINE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ISOPTO ATROPINE
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02858310 results posted | 160154 16-C-0154 | Ph 1, Ph 2 | completed | E7 TCR T Cells for Human Papillomavirus-Associated Cancers |
| NCT05470881 PRO-201 results posted | SOPH201-0521/I | Ph 1 | completed | Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201 |
| NCT06697522 | Protocol V 7.0 | Ph 3 | completed | Study of Atropine Sulfate Eye Drops(0.01%) in Treating Near-work-induced Transient Myopia in Children |
| NCT05481489 PRO-230 | SOPH230-1121/I | Ph 1 | withdrawn | Safety and Tolerability Evaluation of PRO-230 Ophthalmic Solution |
| NCT03690089 CHAMP-UK | 17097AB-AS 2017-004108-23 | Ph 2 | active not recruiting | Low-dose Atropine Eye Drops to Reduce Progression of Myopia in Children in the United Kingdom |
| NCT05372991 | CBT-CS201 | Ph 1, Ph 2 | completed | Safety, Tolerability and Pharmacodynamics Evaluation of CBT-009 Eye Drop |
| NCT03932578 | MSA10 | Ph 4 | completed | Intrathecal Atropine vs IV Metoclopramide for Nausea & Vomiting During CS |
| NCT01858090 | KA08/48 | Ph 3 | completed | Intrathecal Levobupivacaine With Opioids for Caesarean Section |
| NCT00947596 | PRO07030057 | Ph 1 | completed | A Study of Inhaled Atropine Sulfate in Healthy Adults |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ISOPTO ATROPINE FDA Label Details
Indications & Usage
FDA Label (PDF)ISOPTO ATROPINE is indicated for the treatment of Mydriasis; Cycloplegia; Amblyopia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.