FML®

GoodRx

Fluorometholone 0.1% · ophthalmic suspension

Steroid

Approved uses

Corticosteroid-responsive inflammation of the conjunctiva, cornea, and anterior segment

1 drop 2 to 4 times daily; may be increased to 1 drop every 4 hours during the initial 24 to 48 hours

OFF-LABELNot in the FDA label for this product

Moderate to severe dry eye disease

1 drop QID for 22 days (trial regimen)

RCT · n=41 · 22 days only

Single-center double-masked randomized vehicle-controlled trial in 41 patients: at 21 days fluorometholone 0.1% improved corneal and conjunctival staining, hyperemia, and tear break-up time more than polyvinyl alcohol vehicle (P<=0.03), and after a 2-hour controlled adverse environment exposure 23.8% of treated versus 63.1% of vehicle patients worsened by one grade or more of corneal staining (P=0.03). Treatment ran 22 days, so longer-term steroid safety was not assessed.

Pinto-Fraga J, Lopez-Miguel A, Gonzalez-Garcia MJ, et al. Topical Fluorometholone Protects the Ocular Surface of Dry Eye Patients from Desiccating Stress: A Randomized Controlled Clinical Trial. Ophthalmology. 2016;123(1):141-153 (ePub 2015 Oct 29).

Maintenance immunosuppression after Descemet membrane endothelial keratoplasty

After 1 month of prednisolone acetate 1%, fluorometholone 0.1% from month 2: QID through month 3, TID month 4, BID month 5, QD months 6 to 12 (trial regimen)

RCT · n=325 eyes · 1 year

Prospective randomized multicenter trial, 325 eyes: through 1 year, 0 prednisolone versus 2 fluorometholone eyes (1.4%) had a possible or probable rejection episode (P=0.17, both resolved with increased topical steroid), while IOP elevation to 24 mmHg or more, or 10 mmHg or more over baseline, occurred in 6% of fluorometholone versus 22% of prednisolone eyes (P=0.0005). One-year endothelial cell loss was comparable (30% vs 31%, P=0.50). This is the cleanest head-to-head basis for the lower IOP-rise claim against prednisolone.

Price MO, Price FW, Kruse FE, Bachmann BO, Tourtas T. Randomized comparison of topical prednisolone acetate 1% versus fluorometholone 0.1% in the first year after Descemet membrane endothelial keratoplasty. Cornea. 2014;33(9):880-886.

Contraindications

Most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella.
Mycobacterial ocular infection.
Fungal diseases of ocular structures.
Known or suspected hypersensitivity to any ingredient of the preparation or to other corticosteroids.

Available Forms

0.1% suspension, 5 mL, 10 mL.

Mechanism of Action

Corticosteroid; induces phospholipase A2 inhibitory proteins (lipocortins) that block release of arachidonic acid and therefore synthesis of prostaglandins and leukotrienes. Suppresses edema, fibrin deposition, capillary dilation, leukocyte migration, collagen deposition, and scar formation, and probably delays healing.

Warnings & Precautions

Prolonged use: Raises IOP in susceptible individuals, producing glaucoma with optic nerve damage, defects in visual acuity and fields, and posterior subcapsular cataract; it also suppresses host immune response and increases the hazard of secondary ocular infection.
Steroid IOP response: Average time to a rise is significantly longer than with dexamethasone phosphate, but a small percentage of individuals rise significantly within one week and the ultimate magnitude of the rise is equivalent for both drugs.
IOP monitoring: Monitor routinely if the product is used 10 days or longer, including in children and uncooperative patients, and use with caution in existing glaucoma.
Corneal or scleral thinning: Long-term topical steroid use and various ocular diseases thin these tissues, and use over thin cornea or sclera may lead to perforation.
Acute purulent infection: May be masked or its activity enhanced by corticosteroid.
Post-cataract surgery use: May delay healing and increase the incidence of bleb formation.
Viral ocular infection: Course may be prolonged and severity worsened, including herpes simplex; a history of herpes simplex demands great caution and frequent slit lamp microscopy.
Fungal keratitis: Particularly prone to develop with long-term local corticosteroid use; suspect fungal invasion in any persistent corneal ulceration and take cultures where appropriate.
Soft contact lenses: Benzalkonium chloride 0.004% may be absorbed; wait at least 15 minutes after instillation before inserting lenses.
Renewal beyond 20 mL: Initial prescription and renewal past that volume warrant examination with magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

Common Side Effects

Ocular, most frequent: Elevated IOP with possible glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing; the label ranks these in decreasing order of frequency.
Ocular, occasional: Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation, ptosis; transient burning and stinging on instillation and other minor irritation; foreign body sensation, eye pain, pruritus, discharge, increased lacrimation, lid erythema and edema, blurred vision, visual field defect; secondary bacterial, fungal, or viral infection; acute anterior uveitis and perforation of the globe.
Systemic: Extremely uncommon; the label's rare reports of systemic hypercorticoidism come from topical dermatologic steroids applied to the skin, not from ocular dosing. Allergic reactions, rash, and taste perversion have been reported.

Pregnancy & Lactation

Pregnancy: Embryocidal and teratogenic in rabbits at low multiples of the human ocular dose, with dose-related fetal loss, cleft palate, deformed rib cage, anomalous limbs, encephalocele, craniorachischisis, and spina bifida after ocular dosing on gestation days 6 to 18; no adequate human studies; use only if benefit justifies fetal risk.

Lactation: Systemically administered corticosteroids appear in human milk and could suppress growth or interfere with endogenous corticosteroid production; whether topical ocular dosing yields detectable milk levels is unknown; decide between discontinuing nursing and discontinuing the drug.

Pediatric Use

Safety and effectiveness in infants below 2 years of age not established.