Mediclarum
Medicine guide

Miebo

1 mg/mg · Solution

  • Prescription only
  • Semifluorinated Alkane
Active substance
Perfluorohexyloctane
Made by
Bausch & Lomb Incorporated

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-03-10

What it is

Semifluorinated Alkane

Used for
  • MIEBO ® (perfluorohexyloctane ophthalmic solution) is indicated for the treatment of the signs and symptoms of dry eye disease (DED).
Do not take it if

Hypersensitivity. ( 4.1 ) 4.1 Hypersensitivity MIEBO is contraindicated in patients with a history of hypersensitivity reaction to perfluorohexyloctane [see Adverse Reactions ( 6.1 )] .

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • MIEBO ® (perfluorohexyloctane ophthalmic solution) is indicated for the treatment of the signs and symptoms of dry eye disease (DED).
  • MIEBO (perfluorohexyloctane ophthalmic solution) is a semifluorinated alkane indicated for treatment of the signs and symptoms of dry eye disease.
  • ( 1 )

From the official label · 2026-03-10 · DailyMed

How it works

From this product’s own US prescribing label.

Perfluorohexyloctane, a semifluorinated alkane, contains 6 perfluorinated carbon atoms and 8 hydrogenated carbon atoms.

Perfluorohexyloctane forms a monolayer at the air-liquid interface of the tear film which can be expected to reduce evaporation.

How the body breaks it down

Perfluorohexyloctane was not metabolized by human liver microsomes in vitro.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-03-10

Do not take it if

Hypersensitivity. ( 4.1 ) 4.1 Hypersensitivity MIEBO is contraindicated in patients with a history of hypersensitivity reaction to perfluorohexyloctane [see Adverse Reactions ( 6.1 )] .

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • Instill one drop of MIEBO four times daily into each eye.
  • ( 2.1 )
  • 2.1 Recommended Dosage Instill one drop of MIEBO four times daily into affected eye(s).
  • Contact lenses should be removed prior to and for at least 30 minutes after the administration of MIEBO.
  • 2.2 Administration Instructions Step 1.
  • Remove the cap from eye drop bottle.
  • Step 2.
  • Holding the bottle upright, gently squeeze the bottle.
  • Step 3.
  • While squeezing, turn the bottle upside down and release the pressure (drawing air into the bottle).
  • Step 4.
  • Keeping the bottle upside down, place the bottle above your eye and squeeze it again to release a drop into your eye.
  • Repeat steps 1 - 4 for the second affected eye.
  • Step 2.
  • Step 3.
  • Step 4.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

5.1 Use with Contact Lenses MIEBO should not be administered while wearing contact lenses. Advise patients that contact lenses should be removed prior to and for at least 30 minutes after administration of MIEBO.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Risk Summary There are no adequate and well controlled studies with MIEBO in pregnant women.
  • In animal reproduction studies with oral administration of perfluorohexyloctane during the period of organogenesis, no adverse maternal or developmental effects were observed in rats at doses up to 162 times the recommended human ophthalmic dose (RHOD) ( see Data ).
  • Maternal toxicity, miscarriages and reduced fetal weights were observed in rabbits at all doses tested, with the lowest dose as 41 times the RHOD.
  • All pregnancies have a risk of birth defect, loss, or other adverse outcomes.
  • In the US general population, the estimated background risk of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies.
  • Data Animal Data An embryofetal study was conducted in pregnant rabbits administered perfluorohexyloctane by oral gavage on gestation days 6 to 19, to target the period of organogenesis.
  • Perfluorohexyloctane produced maternal toxicity, characterized by reduced body weight gain and food consumption, and miscarriages at all doses tested, with the lowest dose as ≥ 250 mg/kg/day (41 times the RHOD based on body surface area).
  • Reduced fetal weights were also observed at ≥ 250 mg/kg/day but no fetal mortality or malformations.
  • A no observed adverse effect level (NOAEL) for maternal toxicity was not established in rabbits.
  • An embryofetal study was conducted in pregnant rats administered perfluorohexyloctane by oral gavage on gestation days 6 to 17, to target the period of organogenesis.
  • There was no evidence of embryofetal toxicity or teratogenicity at doses up to 2,000 mg/kg/day (162 times the RHOD).
  • IN SPECIFIC POPULATIONS
  • 8.1 Pregnancy Risk Summary There are no adequate and well controlled studies with MIEBO in pregnant women.
  • In animal reproduction studies with oral administration of perfluorohexyloctane during the period of organogenesis, no adverse maternal or developmental effects were observed in rats at doses up to 162 times the recommended human ophthalmic dose (RHOD) ( see Data ).
  • Maternal toxicity, miscarriages and reduced fetal weights were observed in rabbits at all doses tested, with the lowest dose as 41 times the RHOD.
  • All pregnancies have a risk of birth defect, loss, or other adverse outcomes.
  • In the US general population, the estimated background risk of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies.
  • Data Animal Data An embryofetal study was conducted in pregnant rabbits administered perfluorohexyloctane by oral gavage on gestation days 6 to 19, to target the period of organogenesis.
  • Perfluorohexyloctane produced maternal toxicity, characterized by reduced body weight gain and food consumption, and miscarriages at all doses tested, with the lowest dose as ≥ 250 mg/kg/day (41 times the RHOD based on body surface area).
  • Reduced fetal weights were also observed at ≥ 250 mg/kg/day but no fetal mortality or malformations.
  • A no observed adverse effect level (NOAEL) for maternal toxicity was not established in rabbits.
  • An embryofetal study was conducted in pregnant rats administered perfluorohexyloctane by oral gavage on gestation days 6 to 17, to target the period of organogenesis.
  • There was no evidence of embryofetal toxicity or teratogenicity at doses up to 2,000 mg/kg/day (162 times the RHOD).
  • 8.2 Lactation There are no data on the presence of perfluorohexyloctane in human milk, the effects on the breastfed infant, or the effects on milk production.
  • The lack of clinical data during lactation precludes a clear determination of the risk of MIEBO to an infant during lactation; however, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for MIEBO.
  • 8.4 Pediatric Use The safety and effectiveness of MIEBO in pediatric patients below the age of 18 years have not been established.
  • 8.5 Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Use in children

The safety and effectiveness of MIEBO in pediatric patients below the age of 18 years have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Quoted from the official label, section “Geriatric Use”.

Side effects

  • Most common ocular adverse reaction was blurred vision.
  • Blurred vision was reported in less than 4% of individuals.
  • ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • In patients with DED, 614 patients received at least one dose of MIEBO in two randomized controlled clinical trials across 68 sites in the United States.
  • The most common ocular adverse reaction was blurred vision.
  • Blurred vision and conjunctival redness were reported in 1-3% of individuals.
  • In four premarketing studies (three open-label [n=127], one randomized [n=24 treated with at least one dose of perfluorohexyloctane]) the most common adverse reaction was hypersensitivity.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • Use with Contact Lenses Advise patients that contact lenses should be removed prior to and for at least 30 minutes after administration of MIEBO.
  • Administration Instructions Advise patients to instill one drop of MIEBO four times daily into each eye as depicted in the Administration Instructions [see Dosage and Administration ( 2.2 )] .
  • Distributed by: Bausch & Lomb Americas Inc.
  • Bridgewater, NJ 08807 USA Patented.
  • See https://patents.bausch.com for US patent information.
  • MIEBO is a trademark of Bausch & Lomb Incorporated or its affiliates. © 2025 Bausch & Lomb Incorporated or its affiliates 9805301

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

  • FORMS AND STRENGTHS MIEBO (perfluorohexyloctane ophthalmic solution) is a sterile, clear and colorless ophthalmic solution containing 100% perfluorohexyloctane. Ophthalmic solution:
  • 100% perfluorohexyloctane. ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • MIEBO ® (perfluorohexyloctane ophthalmic solution) is supplied as a sterile, clear and colorless liquid in multiple-dose 5 mL polypropylene bottles with dropper tips and screw caps, packaged in a carton - NDC 24208-377-05.
  • Storage Store MIEBO at 15ºC to 25ºC (59ºF to 77ºF).
  • After opening, MIEBO can be used until the expiration date on the bottle.

Quoted from the official label, section “How Supplied”.

What is in it

  • MIEBO ® (perfluorohexyloctane ophthalmic solution) is a sterile, clear and colorless liquid containing 100% perfluorohexyloctane, for topical ophthalmic use.
  • The active ingredient is 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorotetradecane and is a semifluorinated alkane.
  • It has a molecular formula of C 14 H 17 F 13 and a molecular weight of 432.26 g/mol.
  • The chemical structure is: Perfluorohexyloctane is practically immiscible with water.
  • It is miscible with ethanol and most organic solvents.
  • Each multiple-dose bottle contains 3 mL of perfluorohexyloctane, 1.338 g/mL as a clear and colorless liquid.
  • A structure of a chemical formula AI-generated content may be incorrect.

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

CanadaNo exact match for this strength and form

Every strength and form (1)

Details

Made byBausch & Lomb Incorporated
Active substancePerfluorohexyloctane
Strength1 mg/mg
FormSolution
RouteOphthalmic
Packs1 BOTTLE in 1 CARTON / 3 mg in 1 BOTTLE · 1 BOTTLE in 1 CARTON / 1.6 mg in 1 BOTTLE
NDC24208-377

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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