Fluorometholone

Overview

A glucocorticoid employed, usually as eye drops, in the treatment of allergic and inflammatory conditions of the eye. It has also been used topically in the treatment of various skin disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p732)

Indication

For the ophthalmic treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

Associated Conditions

Allergic Conjunctivitis (AC)
Anterior chamber inflammation
Inflammation
Keratitis
Ocular Inflammation
Ocular bacterial infections

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Once-daily Fluorometholone Vs Twice-daily Cyclosporine in Dry Eye Disease	2025/03/14	NCT06876116	Phase 4	Completed	Korea University Anam Hospital
The OPTIMISE Study	2023/02/08	NCT05716945	Phase 4	Not yet recruiting	Maastricht University Medical Center
Comparison of the Postoperative Use of Dextenza vs a Standard Regimen After PRK	2022/10/20	NCT05587231	Phase 4	Not yet recruiting	Navy Medical Center San Diego
Effect of Various Treatment Modalities on Dendritic Vial Ulcer	2022/04/06	NCT05313828	N/A	UNKNOWN	Sohag University
Treatment of Corneal Infiltrates Secondary to Epidemic Keratoconjunctivitis	2020/05/06	NCT04376970	Phase 4	Completed	Military Hospital of Tunis
FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial	2019/11/04	NCT04149210	Phase 3	Completed	Massachusetts Eye and Ear Infirmary
Ocular Micro-vascular Research Base on Functional Slip Lamp Biomicroscopy	2018/11/20	NCT03747614	Phase 4	UNKNOWN	Zhongshan Ophthalmic Center, Sun Yat-sen University
Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery	2016/06/29	NCT02816905	Phase 4	Completed	Cairo University
Efficacy and Safety of Fluorometholone (FML) in Dry Eye Disease (Keratoconjunctivitis Sicca)	2014/01/31	NCT02051023	Phase 3	Completed	Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
The Use of MMC During PRK and Its Effect on Postoperative Topical Steroid Requirements	2014/01/09	NCT02030990	Phase 2	UNKNOWN	United States Naval Medical Center, San Diego

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
fluorometholone ophthalmic suspension	Amneal Pharmaceuticals NY LLC	60219-1586	OPHTHALMIC	1 mg in 1 mL	1/11/2024
FML FORTE	Allergan, Inc.	11980-228	OPHTHALMIC	2.5 mg in 1 mL	12/19/2023
FML	Allergan, Inc.	11980-211	OPHTHALMIC	1 mg in 1 mL	12/20/2023
Flarex	Eyevance Pharmaceuticals	71776-100	OPHTHALMIC	1 mg in 1 mL	10/10/2023
Flarex	Alcon Laboratories, Inc.	0065-0096	OPHTHALMIC	1 mg in 1 mL	12/15/2016
fluorometholone ophthalmic suspension	Amneal Pharmaceuticals NY LLC	60219-1585	OPHTHALMIC	1 mg in 1 mL	1/11/2024
FLUOROMETHOLONE	Pacific Pharma, Inc.	60758-880	OPHTHALMIC	1 mg in 1 mL	11/13/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
FML LIQUIFILM OPHTHALMIC SUSPENSION 0.1%	ALLERGAN PHARMACEUTICALS IRELAND	SIN04347P	SOLUTION	1 mg/ml	5/3/1990

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
TOLON EYE DROPS 0.1%	N/A	LAFARGE CO., LIMITED	N/A	N/A	9/11/2006

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
FML fluorometholone 1mg/mL eye drops bottle	23212	AbbVie Pty Ltd	Medicine	A	10/14/1991
FLAREX Sterile Ophthalmic Suspension Bottle	25278	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	10/15/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PMS-FLUOROMETHOLONE	Pharmascience Inc	02238568	Suspension - Ophthalmic	0.1 %	7/16/2001
FML-NEO OPH SUS	Allergan, Inc.	00395153	Suspension - Ophthalmic	0.1 %	12/31/1977
FML FORTE SUS 0.25%	Allergan, Inc.	00707511	Suspension - Ophthalmic	0.25 %	12/31/1987
SANDOZ FLUOROMETHOLONE	Sandoz Canada, Inc.	00432814	Suspension - Ophthalmic	0.1 %	7/24/2012
FML	Abbvie Corporation	00247855	Suspension - Ophthalmic	0.1 % / W/V	12/31/1972
FLAREX	novartis pharmaceuticals canada inc	00756784	Suspension - Ophthalmic	0.1 % / W/V	12/31/1987

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
SOLUBALM 0,5 mg/g + 100 mg/g CREMA	Arafarma Group S.A.	53774	CREMA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ISOPTO FLUCON 1 MG/ML COLIRIO EN SUSPENSION	Immedica Pharma Ab	56132	COLIRIO EN SUSPENSIÓN	Medicamento Sujeto A Prescripción Médica	Commercialized
FML 1 mg/ml colirio en suspensión	Abbvie Spain, S.L.U.	57606	COLIRIO EN SUSPENSIÓN	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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