Perfluorohexyloctane

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.

• 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.

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

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.

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.

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.

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.

Metabolism

The pharmacokinetics of perfluorohexyloctane following topical ocular administration of MIEBO has not been quantitatively characterized in humans. A single pharmacokinetic (PK) study was conducted that showed low systemic perfluorohexyloctane blood levels after topical ocular administration.

• May 18, 2023NDANDA216675Bausch And Lomb Inc

1. 1Eye Pain21513%
2. 2Vision Blurred21313%
3. 3Eye Irritation20813%
4. 4Inappropriate Schedule Of Product Administration19612%
5. 5Product Delivery Mechanism Issue1589.7%
6. 6Product Use Issue1509.2%
7. 7Ocular Hyperaemia1227.5%
8. 8Product Use Complaint1217.4%
9. 9Circumstance Or Information Capable Of Leading To Medication Error1207.4%
10. 10Drug Ineffective1177.2%
11. 11Exposure Via Skin Contact1016.2%
12. 12Accidental Exposure To Product1006.1%
13. 13Product Complaint996.1%
14. 14Dry Eye965.9%
15. 15Headache925.7%

The 10 most recently updated of 18 ClinicalTrials.gov registrations naming Perfluorohexyloctane as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease
  Recruiting · Phase 4 · Interventional · 260 enrolled · Indiana University
  NCT07243275updated 2026-03-27
• A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease
  Recruiting · Phase 2 · Interventional · 423 enrolled · Bausch & Lomb Incorporated
  NCT07128628updated 2026-03-13
• A Study to Evaluate the Safety and Effectiveness of Perfluorohexyloctane Eye Drops on Treatment of Dry Eye Disease (DED) Related to Meibomian Gland Dysfunction (MGD)
  Not yet recruiting · Observational · 2,000 enrolled · Xiamen Ophthalmology Center Affiliated to Xiamen University
  NCT07457021updated 2026-03-09
• A Study to Evaluate Concomitant Perfluorohexyloctane Use With Contact Lens Wear
  Completed · Phase 4 · Interventional · 104 enrolled · Bausch & Lomb Incorporated
  NCT07054606updated 2025-12-18
• A Study to Assess the Long-Term Safety of Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination in Subjects With Dry Eye Disease
  Withdrawn · Phase 3 · Interventional · 0 enrolled · Bausch & Lomb Incorporated
  NCT07111013updated 2025-12-10
• A Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease
  Completed · Phase 4 · Interventional · 99 enrolled · Bausch & Lomb Incorporated
  NCT06309953updated 2025-10-21
• Effects of NOV03 on the Tear Film
  Completed · Phase 4 · Interventional · 33 enrolled · Bausch & Lomb Incorporated
  NCT05723770updated 2025-07-04
• A Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/Keratometry and Postoperative Refractive Accuracy
  Completed · Phase 4 · Interventional · 97 enrolled · Bausch & Lomb Incorporated
  NCT06346340updated 2025-04-15
• Treating Lid Wiper Epitheliopathy
  Completed · Phase 4 · Interventional · 52 enrolled · Southern College of Optometry
  NCT06671041updated 2025-02-25
• A Study to Evaluate Corneal Endothelial Cell Density (ECD) in Subjects With Dry Eye Disease (DED) Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months.
  Active not recruiting · Phase 4 · Interventional · 216 enrolled · Bausch & Lomb Incorporated
  NCT06565650updated 2024-12-17

Frequently asked questions

How does Perfluorohexyloctane work?

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.

What is Perfluorohexyloctane used for?

According to FDA labeling, Perfluorohexyloctane carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Perfluorohexyloctane?

Perfluorohexyloctane is classified as Semifluorinated Alkane, Unknown Cellular or Molecular Interaction.

What are the brand names for Perfluorohexyloctane?

Perfluorohexyloctane is marketed under brand names including Miebo.

What are the contraindications for Perfluorohexyloctane?

Perfluorohexyloctane labeling lists contraindications including: Hypersensitivity. ( 4.1 ) 4.1 Hypersensitivity MIEBO is contraindicated in patients with a history of hypersensitivity reaction to perfluorohexyloctane [see Adverse Reactions ( 6.1 )] .. Always consult the full prescribing information and a clinician.