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FML 0.1% eyedrops
FML 0.1% eyedrops is a Topical corticosteroid Small molecule drug developed by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA. It is currently in Phase 3 development for Inflammatory and allergic conditions of the anterior segment of the eye (conjunctivitis, keratitis, iritis, iridocyclitis), Post-operative inflammation following ocular surgery. Also known as: 0.1% fluorometholone.
FML (fluorometholone) is a topical corticosteroid that suppresses inflammatory responses in the eye by inhibiting phospholipase A2 and reducing production of inflammatory mediators.
FML (fluorometholone) is a topical corticosteroid that suppresses inflammatory responses in the eye by inhibiting phospholipase A2 and reducing production of inflammatory mediators. Used for Inflammatory and allergic conditions of the anterior segment of the eye (conjunctivitis, keratitis, iritis, iridocyclitis), Post-operative inflammation following ocular surgery.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | FML 0.1% eyedrops |
|---|---|
| Also known as | 0.1% fluorometholone |
| Sponsor | Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA |
| Drug class | Topical corticosteroid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
Fluorometholone is a synthetic glucocorticoid that penetrates ocular tissues and binds to glucocorticoid receptors in the eye. It inhibits the release of arachidonic acid and subsequent production of prostaglandins and leukotrienes, thereby reducing inflammation, edema, and immune cell infiltration in ocular tissues.
Approved indications
- Inflammatory and allergic conditions of the anterior segment of the eye (conjunctivitis, keratitis, iritis, iridocyclitis)
- Post-operative inflammation following ocular surgery
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)
- 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)
- Microvascular and Inflammatory Responses of 0.05 Cyclosporine Eye Drop (II) in Treatment of Dry Eye (NA)
- Treatment of Corneal Infiltrates Secondary to Epidemic Keratoconjunctivitis (PHASE4)
- Efficacy and Safety of Fluorometholone (FML) in Dry Eye Disease (Keratoconjunctivitis Sicca) (PHASE3)
- Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium (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:
- FML 0.1% eyedrops CI brief — competitive landscape report
- FML 0.1% eyedrops updates RSS · CI watch RSS
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA portfolio CI
Frequently asked questions about FML 0.1% eyedrops
What is FML 0.1% eyedrops?
How does FML 0.1% eyedrops work?
What is FML 0.1% eyedrops used for?
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Is FML 0.1% eyedrops also known as anything else?
What drug class is FML 0.1% eyedrops in?
What development phase is FML 0.1% eyedrops in?
What are the side effects of FML 0.1% eyedrops?
What does FML 0.1% eyedrops target?
Related
- Drug class: All Topical corticosteroid drugs
- Target: All drugs targeting Glucocorticoid receptor
- Manufacturer: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Inflammatory and allergic conditions of the anterior segment of the eye (conjunctivitis, keratitis, iritis, iridocyclitis)
- Indication: Drugs for Post-operative inflammation following ocular surgery
- Also known as: 0.1% fluorometholone
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing