What is dry eye disease (DED)?

DED is a multifactorial disorder of the ocular surface characterized by a loss of tear film stability that can occur when any component of the tear film (mucin, aqueous layer, and/or lipid layer) is disrupted, which can lead to a self-perpetuating cycle.

Learn about the vicious cycle of DED and tear evaporation—a leading driver of the disease.

What are the most common causes and symptoms of DED?

A number of risk factors have been associated with DED, including the use of digital devices, lifestyle choices (eg, the use of cosmetics, alcohol use and smoking, the environment [ie, climate, pollutants, allergens]), and certain medical conditions and/or medications. These factors can lead to excessive tear evaporation and/or desiccation stress, which contributes to changes in the tear film that drive the disease. Common symptoms of DED include eye dryness, blurred vision, eye irritation, light sensitivity, eye tiredness, burning and stinging, eye itching, and eye pain.

Learn more about how digital device use, lifestyle, and environmental factors impact the ocular surface.

How is meibomian gland dysfunction (MGD) connected to DED?

The majority of patients with DED have excessive tear evaporation, which is associated with MGD. Normally, the meibomian glands secrete meibum, a key component of the lipid layer of the tear film. Meibum contributes to tear film stability by slowing tear evaporation. MGD is characterized by changes in meibum composition, reduced meibum secretion, and breakdown of the tear film lipid layer. These changes to the tear film result in excess tear evaporation, which drives the cycle of DED.

100% of patients in the MIEBO pivotal trials had clinical signs of MGD, which is associated with excess tear evaporation. MIEBO is the only Rx eye drop for DED that directly targets tear evaporation.

Watch a quick video to see how MIEBO works.

Is there a risk of vision loss or severe complications if DED is left untreated?

DED can cause damage to the ocular surface that is usually reversible. In most patients, DED will not threaten their vision; however, symptoms can negatively impact quality of life. Eliminating factors that lead to tear film disruption leads to improvement. Patients with severe DED and underlying inflammatory conditions may develop complications such as ocular surface keratinization, conjunctival fibrosis/cicatricial changes, limbal stem cell deficiency, corneal scarring, thinning, neovascularization, and microbial or sterile corneal ulceration with possible perforation, and severe vision loss. Early diagnosis and treatment are important.

See how MIEBO works to address tear evaporation, a leading driver of DED. The exact mechanism of action for MIEBO in DED is not known.

How common is excessive tear evaporation in DED?

Excessive tear evaporation is extremely common in DED and is a leading driver of the condition. About 86% of patients with DED have excessive tear evaporation. Excessive tear evaporation causes instability of the tear film and drives a vicious and self-perpetuating cycle of DED.

Learn more about tear evaporation in DED.

How does MIEBO work to treat DED?

MIEBO is the only Rx eye drop for DED that directly targets tear evaporation. It forms a protective, anti-evaporative layer that mimics key functions of natural meibum and addresses damage by promoting healing on the ocular surface. It may also reduce friction. The exact mechanism of action for MIEBO in DED is not known.

Learn more about how MIEBO works by watching a video.

What differentiates the mechanism of action (MOA) of MIEBO from other dry eye treatments?

MIEBO is the only Rx eye drop for DED that directly targets tear evaporation, a leading driver of DED. And MIEBO is the only Rx eye drop with preclinical data supporting evaporation inhibition.

Learn more about what makes MIEBO different.

What is the difference between MIEBO and other DED products made with semifluorinated alkanes?

MIEBO is vehicle free and the only anti-evaporative treatment for DED composed of 100% active perfluorohexyloctane. Perfluorohexyloctane is a unique semifluorinated alkane not found in any other prescription products for DED. It is designed to inhibit the evaporation of tears by forming an anti-evaporative layer on the surface of the eye. The exact mechanism of action for MIEBO in DED is not known.

Learn more about what makes MIEBO different.

How does MIEBO impact tear film stability and tear evaporation?

MIEBO is the only Rx eye drop for DED that directly targets tear evaporation. MIEBO forms a protective layer that helps stabilize the tear film and restore ocular homeostasis. When used as directed, MIEBO can enable healing of the eye over time. The exact mechanism of action for MIEBO in DED is not known.

Learn more about how MIEBO inhibits evaporation by watching a video.

What is perfluorohexyloctane and what’s important to know about it?

Perfluorohexyloctane is a unique semifluorinated alkane not found in any other prescription products for DED. It is designed to inhibit the evaporation of tears by forming an anti-evaporative layer on the surface of the eye. Perfluorohexyloctane is the only ingredient in MIEBO and was extensively studied in clinical trials for efficacy and safety.

Learn more about perfluorohexyloctane and the science behind MIEBO.

Which patients are most likely to benefit from MIEBO?

Since the majority of patients with DED—~86%—have excessive tear evaporation, it could be an appropriate option for many patients in an eye care professional’s practice.

Learn more about how MIEBO addresses tear evaporation in DED.

What were the primary endpoints and efficacy outcomes in MIEBO clinical trials?

MIEBO demonstrated robust, reproducible efficacy and tolerability results across 2 pivotal trials, in which 100% of the patient population had clinical signs of evaporative DED at enrollment.

In these trials, patients using MIEBO (n = 614) experienced rapid improvement in the signs and symptoms of DED as early as ~2 weeks (Day 15), with continued improvement through the end of the trial, ~8 weeks (Day 57). The primary endpoints were total corneal fluorescein staining and eye dryness scores at ~8 weeks (Day 57).

See the full study design and explore data from the pivotal trials.

How soon can patients typically expect to experience relief from symptoms after starting MIEBO?

In a prospective, open-label, single-arm, multicenter, phase 4 study that builds on the pivotal trials, patients reported symptom relief in as fast as 5 minutes. Symptom relief continued through all other time points measured throughout the study: Day 3, Day 7 (primary endpoint), and Day 14 (end of study).

Explore the efficacy data from the pivotal trials and the phase 4 study.

How does long-term use of MIEBO influence meibomian gland function?

MIEBO mimics the key functions of natural meibum by reducing evaporation, reducing friction, and promoting healing of the ocular surface. MIEBO is not known to work directly on meibomian glands.

Explore the long-term data from the 52-week KALAHARI extension study.

What data support patient satisfaction and overall outcomes with MIEBO treatment?

In pivotal trials, the majority of patients rated MIEBO comfortable or very comfortable on instillation. In the long-term KALAHARI extension study, the majority of patients were satisfied with treatment. Patients in the phase 4 study were highly satisfied with MIEBO treatment throughout the study and described MIEBO as silky, smooth, and soothing.

See efficacy data and learn more about patient satisfaction data.

Are there long-term data available for MIEBO?

KALAHARI, an extension of the phase 3 GOBI pivotal trial, evaluated the long-term safety and efficacy of MIEBO in the treatment of DED for 208 patients who continued (N = 97 for MIEBO, N = 111 for saline) for an additional 52 weeks. In KALAHARI, MIEBO demonstrated efficacy and an excellent safety profile, reinforcing results from the MIEBO pivotal trials. The primary safety endpoint was the incidence of ocular and non-ocular adverse events (AEs).

See data for the KALAHARI extension study.

What are the most frequently reported side effects from MIEBO clinical studies?

In clinical trials, blurred vision and conjunctival redness were reported in 1% to 3% of patients.

For more safety data, review the tolerability profile from the MIEBO pivotal trials.

Are there long-term safety data available for MIEBO?

Safety data from a year-long open-label safety extension study, KALAHARI, are available. The extension of the phase 3 GOBI pivotal trial evaluated the long-term safety and efficacy of MIEBO in the treatment of dry eye disease (DED) for 208 patients who continued (N = 97 for MIEBO, N = 111 for saline) for an additional 52 weeks. In KALAHARI, MIEBO demonstrated efficacy and an excellent safety profile, reinforcing results from the MIEBO pivotal trials. The primary safety endpoint was the incidence of ocular and non-ocular AEs.

Learn more about the tolerability profile of MIEBO.

What is the advantage of having a preservative-free formulation?

MIEBO is composed of only 1 ingredient, with no vehicle, preservatives, steroids, or water. Because of its unique formulation, MIEBO is comfortable upon instillation and is also suitable for long-term use. MIEBO was rigorously studied for efficacy and safety and received FDA approval for the treatment of the signs and symptoms of DED. MIEBO has excellent tolerability, which has been consistently demonstrated across pivotal trials, a long-term safety extension study, and a phase 4 study.

Review the consistent safety and tolerability data seen across studies.

Is MIEBO a PFAS? What does that mean for safety?

The term PFAS covers a broad chemical class with thousands of different compounds that have very different structures and properties, some of which are FDA-approved drugs and medical devices that have demonstrated long-term safety.

MIEBO is composed of 100% perfluorohexyloctane (PFHO). PFHO is a semifluorinated alkane, where most PFAS are fluorinated alkyls. The PFHO in MIEBO is inert and nonreactive, so it does NOT change, react with, or bind to other substances. MIEBO is NOT metabolized and does not accumulate in tissues.

The safety of MIEBO was extensively studied, and the FDA has approved MIEBO as safe when used according to its label.

See details of the MIEBO tolerability profile.

Can MIEBO be safely used with contact lenses?

Patients can continue using their contact lenses while being treated with MIEBO. However, MIEBO should not be administered while wearing contact lenses. Contact lenses should be removed before use and for at least 30 minutes after administration of MIEBO.

See more information about MIEBO dosing and instillation.

What is the recommended dosage and administration schedule for MIEBO?

MIEBO has indicated dosing of 1 drop per eye, 4 times a day. MIEBO should not be administered while wearing contact lenses.

See more information about MIEBO dosing and instillation.

How many drops are contained in each bottle, and how long should a bottle typically last for a patient?

MIEBO contains approximately 270 drops. When dosed 4 times daily into each eye, a bottle provides about a 1-month supply. MIEBO is also available in sample bottles. A sample bottle contains approximately 145 drops and provides about a 2-week supply when dosed 4 times daily into each eye.

See more information about MIEBO dosing.

Can MIEBO be used in combination with artificial tears or other ocular medications (eg, glaucoma drops)?

MIEBO has not specifically been studied in combination with artificial tears or other prescription eye drops. However, in the KALAHARI long-term safety extension study, approximately 5% of patients (N = 10) used artificial tears/mineral oil, as permitted, after Week 4 of the study.

See more information about the KALAHARI study design and explore the data.

How often should patients be administering MIEBO? What if a dose is missed?

MIEBO should be administered 1 drop per eye, 4 times a day. If a patient misses a dose of MIEBO, they should administer the missed dose as soon as they remember. However, if it’s almost time for their next scheduled dose, they should skip the missed dose and continue with their regular dosing schedule. Patients should not use extra eye drops to make up for a missed dose.

See more information about MIEBO dosing and instillation.

Are instructional resources available to assist patients with proper application techniques?

To help patients know what to expect from MIEBO, it’s important to let them know that MIEBO may feel different from formulations containing water, and there may be no ocular sensation or blink reflex upon instillation. For tips about applying MIEBO, a step-by-step video created specifically for patients is available at miebo.com.

View and bookmark the patient video about how to use MIEBO.

How much does MIEBO cost with and without insurance coverage?

Two robust patient support and savings programs offer eligible patients 2 ways to pay as little as a $0 copay on their MIEBO prescriptions: BlinkRx and the MIEBO My Savings Program Copay Card.

Learn more about the support and savings programs for MIEBO.

Is MIEBO typically covered by Medicare or private insurance plans?

MIEBO is covered for the majority of patients on commercial and Medicare plans. With the BlinkRx digital prescription service and the MIEBO Copay Card, eligible patients can pay as little as a $0 copay.

See more information on access to MIEBO.

What patient assistance or copay reduction programs are available for MIEBO?

The MIEBO Copay Card and BlinkRx help eligible patients—both commercially insured and Medicare Part D—pay as little as $0.

See the Coverage Grid for more information.

Why is MIEBO prescription only, unlike certain OTC dry-eye products available in Europe?

Approval processes differ between the United States and Europe. In the US, the FDA classified MIEBO (perfluorohexyloctane) as a new drug because it’s a first-in-class treatment with a novel molecule. As a result, it went through the FDA’s rigorous approval process to ensure its safety, efficacy, and manufacturing quality—making it available by prescription only.

In Europe, perfluorohexyloctane is regulated as a medical device, which follows a different pathway and is available over the counter.

Learn more about MIEBO—the only Rx eye drop for DED that directly targets tear evaporation.

Are there resources patients can use for easy fulfillment and cost management?

TBlinkRx can help with easy prescription fulfillment (includes free delivery), prior authorization support, and cost savings. The MIEBO Copay Card can help eligible patients with managing costs (as low as a $0 copay).

Find out more about how to help your patients access MIEBO.