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Fluorometholone 0.1% Oph Susp
Fluorometholone is a topical corticosteroid that suppresses inflammatory and immune responses in the eye by binding to glucocorticoid receptors.
Fluorometholone is a topical corticosteroid that suppresses inflammatory and immune responses in the eye by binding to glucocorticoid receptors. Used for Inflammatory and allergic conditions of the eye, including allergic conjunctivitis, Post-operative inflammation following ocular surgery, Steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.
At a glance
| Generic name | Fluorometholone 0.1% Oph Susp |
|---|---|
| Also known as | FML |
| Sponsor | Maastricht University Medical Center |
| Drug class | Topical corticosteroid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | FDA-approved |
Mechanism of action
Fluorometholone reduces inflammation by inhibiting the release of inflammatory mediators and suppressing immune cell activity in ocular tissues. It is a fluorinated corticosteroid with moderate potency, designed for topical ophthalmic use to minimize systemic absorption while maintaining local anti-inflammatory efficacy.
Approved indications
- Inflammatory and allergic conditions of the eye, including allergic conjunctivitis
- Post-operative inflammation following ocular surgery
- Steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe
Common side effects
- Ocular irritation or discomfort
- Transient blurred vision
- Increased intraocular pressure (with prolonged use)
- Posterior subcapsular cataract formation (with chronic use)
- Secondary ocular infection
Key clinical trials
- FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial (PHASE3)
- The OPTIMISE Study (PHASE4)
- Loteprednol vs. Prednisolone and Fluorometholone (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fluorometholone 0.1% Oph Susp CI brief — competitive landscape report
- Fluorometholone 0.1% Oph Susp updates RSS · CI watch RSS
- Maastricht University Medical Center portfolio CI