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Understanding the Complexity of Dry Eye Disease
Historically, dry eye disease (DED) was oversimplified, often attributed solely to aqueous tear deficiency. However, research shows that approximately 86% of DED cases involve an evaporative component, where the tear film loses stability, leading to faster tear evaporation. This can be due to many factors, including meibomian gland dysfunction, prolonged screen time, and environmental influences.
As professor and optometrist Dr. Chris Lievens explains, “Dry eye sounds so basic—if it’s dry, make it wet. But actually, the science is incredibly complex.” Today’s comprehensive approach to DED considers various aspects of the tear film, including the mucin, aqueous, and lipid layers. It’s the evaporative aspect that MIEBO targets, making it a unique and essential addition to dry eye management.
The Science Behind MIEBO
MIEBO is the only Rx eye drop for DED that directly targets tear evaporation. Its active and only ingredient, perfluorohexyloctane forms a protective layer on the eye’s surface. The dual properties of this molecule—aerophilic (high affinity for air) and lipophilic (high affinity for fats/oils)—allow it to form a monolayer on the surface of the eye that inhibits evaporation. Although the exact mechanism of action for MIEBO in DED is not known, MIEBO can help provide patients with an effective way to manage tear evaporation: the leading cause of DED.
Dr. Jenn Lyerly, an optometrist, states, “The tear film is not a simple sandwich layer; it’s a matrix. And when it’s out of homeostasis, it disrupts everything from contact lens wear to surgical outcomes. The protective layer of MIEBO addresses this complex structure, providing relief.”
Clinical Data and Real-World Results
In its pivotal phase 3 trials, GOBI and MOJAVE, MIEBO was shown to significantly improve both objective and subjective measures of dry eye. These trials involved over 1200 participants, of which 614 patients received MIEBO, providing a solid sample size for reliable results. Researchers measured 2 primary endpoints: total corneal fluorescein staining (tCFS) and the patient-reported eye dryness score. Results indicated that by ~8 weeks, there was a 2x improvement in tCFS vs the control and a 1.5x improvement in eye dryness vs the control. At ~2 weeks is when significant improvement was first noted.
Dr. Jessilin Quint, a leading voice in dry eye disease management, noted that the trial design mirrored real-world conditions, addressing both signs and symptoms. The level of improvement at Day 15 means that patients can experience relief relatively quickly.
Key Differences in the MIEBO Experience
One of the standout features of MIEBO for practitioners is its excellent tolerability profile.* In the pivotal trials, 1% to 3% of patients reported blurred vision and conjunctival redness, making MIEBO not only an efficacious drop for DED, but a tolerable one, too.
Further, the small drop size of MIEBO (11 μL) means patients may not feel it upon instillation. “Setting clear expectations is critical,” says Dr. Quint. “I tell my patients that MIEBO might not trigger a blink reflex and any initial blur will fade quickly. Once they know what to expect, they’re more likely to stay the course.” Reminding patients to follow the administration instructions in the Prescribing Information can help to ensure correct instillation of the drop.
For patients who wear contact lenses: MIEBO should not be administered while wearing them. Contact lenses should be removed before use and for at least 30 minutes after administration of MIEBO. This factor may require planning, but with counseling many patients find that the benefits of decreased dry eye symptoms and reduced evaporation are worth the effort.
Real-World Impact of MIEBO in Practice
“Dry eye doesn’t discriminate,” says Dr. Quint. This may be especially true for certain patients, including those who spend a lot of time using digital devices. These patients may be more likely to develop evaporative DED due to the increased screen time. In such cases, MIEBO can help because it forms a long-lasting barrier on the surface of the eye, which inhibits tear evaporation.†
Educating Patients on Their DED Diagnosis
A crucial component to the success of MIEBO lies in how optometrists communicate the reality of DED to their patients. In the US, millions suffer from DED, but many patients are unaware that they have a diagnosable condition and attribute symptoms to allergies or other benign causes. Dr. Lyerly mentions, “We need to be explicit with patients that dry eye disease is a chronic condition that can impact long-term vision health.”
This distinction helps providers emphasize the importance of compliance and allows patients to understand the necessity of prescribed treatments rather than relying solely on over-the-counter drops. MIEBO enables practitioners to offer a targeted approach with rapid and sustained results‡ and long-term management capabilities.
The Future of Dry Eye Treatment
With MIEBO, the dry eye field is witnessing a significant shift. Its novel mechanism,¶ excellent tolerability profile, and broad application potential make it a valuable tool for eye care professionals managing DED. The data-backed results and real-world stories of patient relief underscore the medication’s potential.
As Dr. Quint succinctly says, “We’re in an exciting era for dry eye treatment. MIEBO represents more than just another option; it’s a new standard that can address evaporative dry eye in a way that meets the real-world demands of our patients.”
*Data were pooled from >1200 total patients from 2 pivotal clinical studies (GOBI and MOJAVE). Of the 614 patients who received MIEBO, there were no incidences of serious ocular adverse events (AEs) with MIEBO. Most AEs were considered mild. The discontinuation rate for MIEBO due to AEs was comparable to control (pooled: 0.2% vs 0.5%; GOBI: 0.3% vs 1.0%; MOJAVE: 0% vs 0%). 0.5% (pooled) of patients experienced instillation site pain AEs, such as burning or stinging (GOBI: 1.0%; MOJAVE: 0%). Blurred vision (pooled: 2.1%; GOBI: 3.0%; MOJAVE: 1.3%) and conjunctival redness (pooled: 0.8%; GOBI: 0%; MOJAVE: 1.3%) were reported in 1% to 3% of patients.†The ocular distribution of perfluorohexyloctane (PFHO) was assessed following ocular topical dosing of radiolabeled 14C-PFHO in 2 studies of 14 Dutch-Belted rabbits. Rabbits received either a single instillation or repeated topical ocular doses. After the last instillation, ocular tissues were collected at multiple time points through 24 hours and radioactivity in the individual collected tissues was measured by liquid scintillation counting. Levels of 14C-PFHO were observed in the tears through at least 6 hours in both studies.
‡MIEBO demonstrated significant improvements in total corneal fluorescein staining and eye dryness in ~2 weeks, with ongoing improvement through the end of the pivotal trials (Day 57, primary endpoint).
¶The exact mechanism of action for MIEBO in DED is not known.
INDICATION
MIEBO® (perfluorohexyloctane ophthalmic solution) is indicated for the treatment of the signs and symptoms of dry eye disease.
IMPORTANT SAFETY INFORMATION
- MIEBO is contraindicated in patients with known hypersensitivity to perfluorohexyloctane
- 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
- Instruct patients to instill one drop of MIEBO into each eye four times daily
- The safety and efficacy in pediatric patients below the age of 18 have not been established
- In pivotal trials, the most common ocular adverse reaction was blurred vision (1% to 3% of patients reported blurred vision and conjunctival redness)
Please see full Prescribing Information for MIEBO at MIEBO-ECP.COM.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
