Miebo: FDA Approved Treatment for dry eye disease 

Introduction

Miebo (perfluorohexyloctane ophthalmic solution) is a prescription eye drop medication that provides symptomatic relief for dry eye disease associated with meibomian gland dysfunction (MGD). It works by forming a layer of oil on the surface of the eye, preventing tear evaporation and keeping the eyes moist and comfortable.

Dry eye disease occurs when there is insufficient tear production to keep the eyes adequately lubricated or when tears do not function properly due to an imbalance in the tear lipid layer.

Excessive tear evaporation is a common cause of dry eye disease, often linked to dysfunction in the Meibomian glands. Situated along the eyelid’s edge where eyelashes are present, these glands produce an essential oil that contributes to the tear film, preventing rapid evaporation of tears. In cases where tears evaporate too quickly, the eyes can become dry and inflamed, leading to potential damage to the eye’s surface. 

Manufacturer

Miebo is manufactured by Bausch Health US, Inc., a leading global pharmaceutical company dedicated to developing and delivering innovative eye care solutions.

FDA Details

Miebo received approval from the U.S. Food and Drug Administration (FDA) in 2023 as the first and only prescription eye drop medication specifically designed to address the underlying cause of dry eye associated with MGD.

Indications

Miebo is indicated for the treatment of dry eye disease associated with meibomian gland dysfunction (MGD). MGD is a common condition characterized by the malfunction of meibomian glands, which are responsible for producing the oily layer of tears. This deficiency leads to excessive tear evaporation, causing dry, irritated, and uncomfortable eyes.

Dosage and Administration

The recommended dosage of Miebo is one drop instilled one drop of Miebo four times daily into each eye. Contact lenses should be removed before installing Miebo and should remain out for at least 30 minutes after administration. 

To administer Miebo, follow these instructions:

1. Remove the cap from the eye drop bottle.
2. Hold the bottle upright and gently squeeze it.
3. While squeezing, turn the bottle upside down and release the pressure, allowing air to enter the bottle.
4. Keep the bottle upside down, position it above your eye, and squeeze again to release a drop into your eye.

Repeat these steps (1-4) for the second affected eye.

Contraindications

Miebo eye drop is contraindicated in patients with a known hypersensitivity to perfluorohexyloctane (FHO) or any of the other components of the medication.

Warnings and Precautions

• Avoid contact with the cornea: Direct contact of Miebo with the cornea may cause temporary stinging or burning.
• Discontinue use if  irritation persists: If eye irritation or discomfort persists after using Miebo, discontinue use and consult your doctor.
• Contact lens use: Contact lenses should be removed before installing Miebo and should remain out for at least 30 minutes after administration.

Usage Of Miebo In Specific Population 

• Pregnancy: The safety of Miebo in pregnant women has not been established as there are no adequate and well-controlled studies.
• Lactation: No data are available regarding the presence of perfluorohexyloctane in human milk, its effects on the breastfed infant, or its impact on milk production.
• Pediatric Use: The safety and effectiveness of Miebo have not been established in pediatric patients below the age of 18.
• Geriatric Use: No notable differences in safety and effectiveness have been observed between elderly and younger patients.

Side Effects

The most common side effects of Miebo include:

•  Temporary stinging or burning upon instillation
•  Blurred vision
•  Eye irritation
•  Redness
•  Headache

These side effects are typically mild and transient. If any side effects become severe or persistent, discontinue the use of Miebo and consult your doctor.

Storage Conditions

Store Miebo at room temperature (20°C to 25°C) in a dark place. Do not refrigerate or freeze Miebo. Keep the medicine away from pets and children. 

How To Buy Miebo Online?

Acquiring Miebo is now a convenient process through online channels, especially for individuals in the US and Europe. To initiate this process, you can get in touch with the SANSFRO team or other reputable firms specializing in importing medications from these regions.

For detailed information on the Miebo cost in the Indian market and specifics regarding procurement, please reach out to our dedicated Patient Support Team at ‎(+91) 93157 05373 or via email at help@sansfro.com. Our team is dedicated to providing accurate and current cost details for Miebo in the Indian market. Ensure a seamless experience in accessing this essential medication by connecting with our trusted services.

Conclusion

Miebo represents a significant advancement in the treatment of dry eye disease associated with meibomian gland dysfunction (MGD). Its unique mechanism of action targets the underlying cause of dry eye by forming a protective layer on the tear surface, providing relief from symptoms and improving overall eye comfort. With its proven efficacy and favorable safety profile, Miebo offers a promising new option for patients struggling with MGD-related dry eye disease.

FAQs

1. Is Miebo safe for children?

The safety and efficacy of Miebo in pediatric patients have not been established.

2. Is Miebo available over the counter or by prescription only?

Miebo is available by prescription only.

3. Is Miebo safe for pregnant women?

There are no adequate and well-controlled studies with Miebo in pregnant women. Consult with a healthcare professional for personalized advice.

4. Can I use Miebo with contact lenses?

No, Miebo should not be administered while wearing contact lenses. Remove them before and wait at least 30 minutes after using Miebo.

Reference:

1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216675s000lbl.pdf
2. https://www.drugs.com/Miebo.html