TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

FLUOROMETHOLONE

FLUOROMETHOLONE Corticosteroid Hormone Receptor Agonists
Ophthalmology Approved 2024-01-09
2
Indications
--
Phase 3 Trials
2
Years on Market

Details

Status
Prescription
First Approved
2024-01-09
Routes
OPHTHALMIC
Dosage Forms
SUSPENSION/DROPS

Companies

Active Ingredient: FLUOROMETHOLONE

FLUOROMETHOLONE Approval History

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What FLUOROMETHOLONE Treats

2 indications

FLUOROMETHOLONE is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Inflammation of the conjunctiva
  • Inflammation of the cornea
Source: FDA Label
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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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.

FLUOROMETHOLONE FDA Label Details

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Indications & Usage

Fluorometholone ophthalmic suspension 0.1% is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.