Miebo 1.3gm/ml Opth Sol 3ml
It is used to treat dry eyes.
Drug Class
Ophthalmic agent for dry eye disease
Pharmacologic Class
Perfluorocarbon ophthalmic solution
Pregnancy Category
Not available
FDA Approved
May 2023
DEA Schedule
Not Controlled
Overview
What is this medicine?
Miebo is an eye drop used to treat dry eye disease. It works by helping to stabilize the natural tear film on the surface of your eye, which reduces the evaporation of your tears. This helps to keep your eyes moist and comfortable, relieving symptoms like dryness, burning, and irritation.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use the medication as directed, even if your symptoms improve.
Administration Instructions
1. Wash your hands before and after using the medication.
2. For ocular use only.
3. To administer the medication, gently squeeze the bottle, then turn it upside down. Release the pressure on the bottle.
4. Tilt your head back, place the tip of the bottle above your eye, and squeeze again to release the medication.
5. Remove contact lenses before using the medication. You can put your lenses back in 30 minutes after administering the medication, unless your eyes are irritated or infected.
Important Safety Precautions
* Avoid touching the container tip to your eye, lid, or other skin, as this can contaminate the medication and lead to severe eye problems or vision loss.
Storage and Disposal
Store the medication at room temperature in a dry place, away from bathrooms. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist, who may be aware of drug take-back programs in your area.
Missed Dose Instructions
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use the medication as directed, even if your symptoms improve.
Administration Instructions
1. Wash your hands before and after using the medication.
2. For ocular use only.
3. To administer the medication, gently squeeze the bottle, then turn it upside down. Release the pressure on the bottle.
4. Tilt your head back, place the tip of the bottle above your eye, and squeeze again to release the medication.
5. Remove contact lenses before using the medication. You can put your lenses back in 30 minutes after administering the medication, unless your eyes are irritated or infected.
Important Safety Precautions
* Avoid touching the container tip to your eye, lid, or other skin, as this can contaminate the medication and lead to severe eye problems or vision loss.
Storage and Disposal
Store the medication at room temperature in a dry place, away from bathrooms. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist, who may be aware of drug take-back programs in your area.
Missed Dose Instructions
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or extra doses.
Lifestyle & Tips
- Use as directed by your doctor, typically one drop in each eye twice a day.
- Do not touch the dropper tip to any surface to avoid contamination.
- If you wear contact lenses, remove them before using Miebo and wait at least 15 minutes before reinserting them.
- If you are using other eye drops, wait at least 5 minutes between applications.
- Store the bottle upright at room temperature (59°F to 77°F or 15°C to 25°C). Do not freeze.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One drop in each eye twice daily (approximately 12 hours apart)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; minimal systemic absorption
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Perfluorohexyloctane is a semifluorinated alkane that forms a monolayer at the air-liquid interface of the tear film, reducing tear evaporation. It is thought to spread rapidly across the ocular surface, integrating into the lipid layer of the tear film, thereby preventing excessive evaporation of the aqueous layer and stabilizing the tear film. This addresses a primary cause of dry eye disease, particularly evaporative dry eye.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal to undetectable systemic absorption
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical ophthalmic)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Improvement in signs and symptoms observed within 2-4 weeks in clinical trials
PeakEffect:
Not precisely defined, sustained improvement over treatment period
DurationOfAction:
Maintained with twice-daily dosing
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening side effect:
- Signs of an allergic reaction, such as:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin, with or without fever
- Wheezing
- Tightness in the chest or throat
- Trouble breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor if you experience any of the following side effects or if they persist or bother you:
- Blurred vision
- Eye redness
Note: This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening side effect:
- Signs of an allergic reaction, such as:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin, with or without fever
- Wheezing
- Tightness in the chest or throat
- Trouble breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor if you experience any of the following side effects or if they persist or bother you:
- Blurred vision
- Eye redness
Note: This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Persistent or worsening eye pain
- Changes in vision
- Continued redness or irritation of the eye
- Signs of eye infection (e.g., pus, severe swelling)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or exacerbate existing health problems.
* Any health issues you are experiencing, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or exacerbate existing health problems.
* Any health issues you are experiencing, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are pregnant, planning to become pregnant, or are breast-feeding, be sure to discuss this with your doctor. You and your doctor will need to carefully weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely to occur with topical ophthalmic use due to minimal systemic absorption.
What to Do:
If accidental ingestion occurs, contact a poison control center or seek medical attention. For ocular overdose, flush eyes with water. Call 1-800-222-1222 for poison control.
Drug Interactions
Monitoring
Baseline Monitoring
Ophthalmic examination
Rationale: To assess baseline ocular health and severity of dry eye disease
Timing: Prior to initiation of therapy
Dry eye symptom assessment (e.g., OSDI score)
Rationale: To quantify baseline symptom burden and track improvement
Timing: Prior to initiation of therapy
Routine Monitoring
Assessment of dry eye symptoms (e.g., dryness, irritation, foreign body sensation)
Frequency: Periodically, as clinically indicated (e.g., at follow-up visits)
Target: Reduction in symptom severity
Action Threshold: Lack of improvement or worsening symptoms may warrant re-evaluation
Ocular surface examination (e.g., tear film breakup time, corneal staining)
Frequency: Periodically, as clinically indicated
Target: Improvement in objective signs of dry eye
Action Threshold: Lack of improvement or worsening signs may warrant re-evaluation
Symptom Monitoring
- Blurred vision
- Eye redness
- Eye discharge
- Eye irritation
- Eyelid swelling
- Foreign body sensation
- Burning or stinging
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Miebo in pregnant women. However, perfluorohexyloctane is minimally absorbed systemically following topical ocular administration, and maternal use is not expected to result in fetal exposure to the drug. Use during pregnancy should be considered if clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk expected due to minimal systemic absorption.
Second Trimester:
Low risk expected due to minimal systemic absorption.
Third Trimester:
Low risk expected due to minimal systemic absorption.
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. Due to minimal systemic absorption, maternal use is not expected to result in exposure of breastfed infants to the drug. Breastfeeding is generally considered compatible with this medication.
Infant Risk:
Low risk expected due to minimal systemic absorption.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended in this population.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger adult patients in clinical trials. No dosage adjustment is necessary based on age.
Clinical Information
Clinical Pearls
- Miebo is a novel, non-aqueous eye drop that specifically targets tear film evaporation, a common cause of dry eye disease.
- Patients should be instructed on proper instillation technique to avoid contamination and ensure optimal delivery.
- Due to its unique mechanism, it can be a valuable option for patients who have not responded adequately to traditional aqueous-based artificial tears or anti-inflammatory drops.
- Minimal systemic absorption means a very low risk of systemic side effects or drug interactions, making it a safe option for many patients.
Alternative Therapies
- Artificial tears (various formulations)
- Cyclosporine ophthalmic emulsion (Restasis, Cequa)
- Lifitegrast ophthalmic solution (Xiidra)
- Loteprednol etabonate ophthalmic suspension (Eysuvis)
- Diquafosol tetrasodium ophthalmic solution (Diquas - not available in US)
- Rebamipide ophthalmic suspension (Mucosta - not available in US)
- Punctal plugs
- Warm compresses and lid hygiene
Cost & Coverage
Average Cost:
Check current pricing per 3ml bottle
Insurance Coverage:
Tier 2 or 3 (Specialty/Non-preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate timely and effective treatment.