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Flarex (FLUOROMETHOLONE ACETATE)
Flarex (fluorometholone acetate) is a corticosteroid medication originally developed by Alcon and currently owned by Harrow Eye. It targets the glucocorticoid receptor to reduce inflammation in the eye. Flarex is approved to treat various ocular conditions, including allergic conjunctivitis, corneal abrasions, and post-operative ocular inflammation. The medication is a small molecule corticosteroid that is off-patent, meaning it is no longer protected by active patents. As a result, there are currently no generic manufacturers of Flarex.
At a glance
| Generic name | FLUOROMETHOLONE ACETATE |
|---|---|
| Sponsor | Harrow Health |
| Drug class | Corticosteroid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1986 |
Approved indications
- Steroid-responsive inflammatory conditions of the eye
Common side effects
- Glaucoma with optic nerve damage
- Visual acuity and field defects
- Cataract formation
- Secondary ocular infection following suppression of host response
- Perforation of the globe
- Dysgeusia
Key clinical trials
- Loteprednol vs. Prednisolone and Fluorometholone (PHASE4)
- Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas
- Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
- Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK) (PHASE2)
- Usefulness of Topical Non-Steroidal Anti-Inflammatory Drugs or Steroids Before Trabeculectomy and Clinical Outcomes (PHASE3)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Flarex CI brief — competitive landscape report
- Flarex updates RSS · CI watch RSS
- Harrow Health portfolio CI