Drugs / Fluorometholone
Fluorometholone
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | FML | — | 1972-01-12 | fda.gov ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT07308938 | Oct 2026 → Dec 2029 expected | corneal ulcer | Vishal Jhanji | Not yet recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02030990 | Aug 2014 → Jan 2023 | corneal disorder | United States Naval Medical Center, San Diego | Unknown | No outcome recorded |
| Phase 32 trials · 1 missed | ||||||
| Phase 3 | NCT04149210 | Aug 2021 → Nov 2024 | eyelid disorder, trachoma | Massachusetts Eye and Ear Infirmary | Completed | Missed primary |
| Phase 3 | NCT02051023 | Feb → Dec 2014 | dry eye syndrome | Institute of Applied Ophthalmobiology - IOBA | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT07553455 | Apr → Dec 2026 expected | dry eye syndrome | Canyon City Eyecare | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06498440 | Sep 2024 → Jul 2025 overdue | ocular hypertension, open-angle glaucoma | St. Joseph's Healthcare Hamilton | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05716945 | Jul 2024 → Sep 2028 expected | Fuchs' endothelial dystrophy, bullous keratopathy, ocular hypertension | Maastricht University Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT07588074 | May → Jun 2021 | dry eye syndrome | Harrow Inc | Completed | No outcome recorded |
| Phase 4 | NCT03747614 | Jun 2017 → Jun 2020 | dry eye syndrome | Zhongshan Ophthalmic Center, Sun Yat-sen University | Unknown | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT01949454 | Nov 2013 → Apr 2016 | eyelid disorder, trachoma | University of Pennsylvania | Completed | No outcome recorded |
| — | NCT01682421 | Sep 2012 | bullous keratopathy, corneal endothelial dystrophy | Aarhus University Hospital | Withdrawn | No outcome recorded |
| — | NCT01562795 | Mar → Jun 2012 | dry eye syndrome | Wenzhou Medical University | Completed | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 1 | NCT05331859 Comparator | May → Aug 2022 | corneal disorder | Benha University | Unknown | No outcome recorded |
| Phase 2 | NCT01448213 Comparator | Oct 2011 → Jan 2014 | Fuchs' endothelial dystrophy, bullous keratopathy | Price Vision Group | Completed | No outcome recorded |
| Phase 2 | NCT00824811 Background | Jun 2009 → ? | excessive tearing | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00707421 Comparator | Jul 2005 → May 2009 | glaucoma | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 4 | NCT05587231 Comparator | Oct 2022 → Oct 2024 | — | Navy Medical Center San Diego | Unknown | No outcome recorded |
| Phase 4 | NCT06876116 Comparator | Sep 2022 → Mar 2024 | dry eye syndrome | Korea University Anam Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05771194 Background | Feb 2021 → Mar 2022 | eyelid disorder | Tianjin Medical University Eye Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02974387 Comparator | Apr → Aug 2017 | — | Dr Salouti Eye Research Center | Unknown | No outcome recorded |
| Phase 4 | NCT02816905 Comparator | Oct 2015 → Jun 2016 | ocular hypertension | Cairo University | Completed | No outcome recorded |
| — | NCT02147509 Background | Mar 2013 → Apr 2014 | Sjogren syndrome | Jinyang Li | Completed | No outcome recorded |
| — | NCT01288404 Comparator | Jan 2008 → Sep 2010 | conjunctival pterygium | Ramathibodi Hospital | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2023-10-24 | Harrow Inc | Harrow Completes Transfer of NDAs and Launches FLAREX®, NATACYN®, TOBRADEX® ST, VERKAZIA®, and ZERVIATE® in the U.S. harrow.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fluorometholone | “Topical moxifloxacin 0.5% (Vigamox; Alcon Laboratories) four times per day, artificial tears (Systane Ultra; Alcon) every two hours, Dexamethasone 0.1% (Maxidex; Alcon...” NCT05331859 ↗20“Initial treatment with dexamethasone 6x per day for two weeks, followed by Fluorometholone 4x per day for 2 months, 3x per day for 2 months, 2x per day for 2 months, and...” NCT01682421 ↗ “0.1% fluorometholone (San Tian Pharmaceutical Co., Ltd., China) was administered 4 times daily” NCT05771194 ↗ “Ocular topical application of fluorometholone 0.1% 4 times a day during 22 days” NCT02051023 ↗ “0.02% Fm: 0.02% Fluorometholone” NCT02147509 ↗ “Fluorometholone” NCT01562795 ↗ |
| Known as | Efemyo | “Topical moxifloxacin 0.5% (Vigamox; Alcon Laboratories) four times per day, artificial tears (Systane Ultra; Alcon) every two hours, Dexamethasone 0.1% (Maxidex; Alcon...” NCT05331859 ↗ |
| Known as | Flarex | “Flarex (fluorometholone acetate ophthalmic suspension) is administered four times daily (QID) in both eyes.” NCT07553455 ↗ |
| Known as | fluorometholone acetate | “Flarex (fluorometholone acetate ophthalmic suspension) is administered four times daily (QID) in both eyes.” NCT07553455 ↗ |
| Known as | FML | “Efficacy and Safety of Fluorometholone (FML) in Dry Eye Disease (Keratoconjunctivitis Sicca)” NCT02051023 ↗2“Adjunctive Topical Fluorometholone (FML) 0.1% will be used” NCT07308938 ↗ “Fluorometholone(FML)” NCT02974387 ↗ |
| Known as | FML Forte | “FML Forte® is also known as fluorometholone 0.25% ophthalmic suspension (fluorometholone eye drops).” NCT00824811 ↗ |
| Modality | Other / unclassified | “Topical steroid” NCT02816905 ↗ |
| Route | Topical | “topical study medication” NCT00707421 ↗ |