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Fluorometholone(FML)
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 (conjunctivitis, keratitis, iritis), Post-operative ocular inflammation, Steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.
At a glance
| Generic name | Fluorometholone(FML) |
|---|---|
| Sponsor | Dr Salouti Eye Research 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 (conjunctivitis, keratitis, iritis)
- Post-operative ocular inflammation
- 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
- Elevated 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)
- Fluorometholone Study (PHASE2)
- The OPTIMISE Study (PHASE4)
- Efficacy of NSAID vs. Steroid-NSAID Combo Post-Selective Laser Trabeculoplasty: Phase 4, Single-Center RCT (PHASE4)
- Dual-Polymer Hydroxypropyl Guar-and Hyaluronic Acid Lubricants in Rheumatoid Arthritis (PHASE4)
- Efficacy and Safety of Dextenza Compared to Topical Fluorometholone in Patients With Ocular Rosacea (PHASE4)
- The Use of MMC During PRK and Its Effect on Postoperative Topical Steroid Requirements (PHASE2, PHASE3)
- Microvascular and Inflammatory Responses of 0.05 Cyclosporine Eye Drop (II) in Treatment of Dry Eye (NA)
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(FML) CI brief — competitive landscape report
- Fluorometholone(FML) updates RSS · CI watch RSS
- Dr Salouti Eye Research Center portfolio CI