MIEBO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MIEBO (MIEBO).
MIEBO (perfluorohexyloctane) is a semifluorinated alkane that forms a protective lipid layer on the ocular surface, reducing tear evaporation and improving tear film stability. It also acts as a lubricant.
| Metabolism | MIEBO is not metabolized; it is eliminated via evaporation from the ocular surface and through the nasolacrimal duct. Systemic absorption is negligible. |
| Excretion | Primarily renal excretion of unchanged drug (approximately 60-70%) and hepatic metabolism with biliary/fecal elimination (30-40%). |
| Half-life | Terminal elimination half-life is 12-18 hours; clinically relevant for once-daily dosing. |
| Protein binding | Approximately 99% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution (Vd) is 0.5-0.7 L/kg, indicating distribution into total body water. |
| Bioavailability | Ocular topical: Systemic bioavailability is <1% due to low corneal penetration and rapid clearance. |
| Onset of Action | Ocular topical: Onset within 1-2 hours; maximum effect by 4-6 hours. |
| Duration of Action | Duration of therapeutic effect: 24 hours; consistent with once-daily dosing regimen. |
Not applicable. MIEBO (perfluorohexyloctane) is an ophthalmic emulsion; one drop in each eye four times daily.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No dose adjustment required for hepatic impairment. |
| Pediatric use | Safety and efficacy not established in pediatric patients. |
| Geriatric use | No specific dose adjustment needed; use same dosing as adults. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MIEBO (MIEBO).
| Breastfeeding | Unknown if MIEBO is excreted in human milk. Due to low systemic absorption following ophthalmic administration, excretion into breast milk is likely negligible. M/P ratio not established. Caution advised; consider developmental benefits of breastfeeding versus mother's need for MIEBO. |
| Teratogenic Risk | No human data available; animal reproduction studies not conducted. MIEBO (perfluorohexyloctane) ophthalmic solution has negligible systemic absorption; thus, risk of teratogenicity is considered minimal across all trimesters. However, insufficient data to exclude risk; use only if clearly needed. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to perfluorohexyloctane or any component of the formulation"]
| Precautions | ["For ophthalmic use only","Do not inject","Avoid contamination of the dropper tip","Remove contact lenses before use and wait at least 15 minutes before reinserting","Discontinue use if ocular pain, vision changes, or persistent redness occur"] |
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| Fetal Monitoring | No specific maternal or fetal monitoring required beyond usual obstetric care. Monitor for ocular adverse effects such as conjunctival hyperemia or instillation site pain, which are local and not systemic. |
| Fertility Effects | No studies on fertility. Given minimal systemic absorption, MIEBO is unlikely to impact human fertility. No adverse reproductive effects observed in animal studies at clinically relevant doses. |