As dry eye disease (DED) continues to be a key area of interest for modern eyecare practitioners, discussing developments in pharmaceutical agents that target the unmet needs of dry eye patients is critical.
In this episode of Interventional Mindset, Preeya K. Gupta, MD, and Kelly K. Nichols, OD, MPH, PhD, FAAO, sit down to review the Food and Drug Administration (FDA) approval of MIEBO (100% perfluorohexyloctane ophthalmic solution, Bausch + Lomb) in May 2023, and how this novel prescription treatment can be incorporated into DED protocols.1
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Identifying existing disparities in dry eye treatments
As a clinical researcher with a focus on the meibomian glands, Dr. Nichols expressed her excitement for MIEBO as a treatment that addresses evaporative dry eye, considering that a high percentage of dry eye has an evaporative component.2
While there are effective in-office DED treatments, having an available topical dry eye treatment targeting evaporation provides clinicians with an additional option in their dry eye armamentarium.
Current research estimates that there are approximately 38 million people in the United States who suffer from dry eye symptoms, while approximately 18 to 20 million patients have been diagnosed with DED.3-7 Interestingly, though, only 1.2 to 1.5 million dry eye prescriptions have been written annually for these patients.3,4,8
This indicates a significant disparity between patients using over-the-counter (OTC) eye drops—which largely have palliative effects—and prescription treatments with formulas designed to address the root cause of their symptoms.
Dr. Gupta noted that in her professional opinion, meibomian gland dysfunction (MGD) is a prevalent contributor to dry eye, and she sees it frequently in her patients. Of note, in the clinical trials for MIEBO, all of the patients had some level of MGD (which was measured on a grading scale), demonstrating its efficacy in treating patients with varying degrees of MGD.
Overview of MIEBO
While MIEBO is indicated for the signs and symptoms of DED, its formula was designed to specifically target the evaporative component of dry eye—though it is beneficial for all DED patients who may require tear film stabilization and prevention of aqueous tear evaporation.
What distinguishes MIEBO from other topical treatments is that it has a water- and preservative-free formula, in which the molecule itself is the therapeutic. As such, the molecule does not require modulation to adjust its pH, allowing for improved comfort during drop instillation.
Dr. Nichols emphasized that in her experience, the drop feels silky and smooth on contact—unlike most other eye drops—demonstrating an ability to form a long-lasting coating of the ocular surface with the potential to prevent tear evaporation.
Further, she is interested in evaluating prospective studies that might investigate how MIEBO could inhibit friction from mechanical dry eye. She projects that future studies could explore this aspect because past clinical trials demonstrated that patients with existing corneal staining—a requirement for inclusion in the study—had improvements in their corneal staining.
Compared to traditional anti-inflammatory or immunomodulatory therapies, MIEBO lowers surface tension to make blinking and the spread of the tear film more consistent. Dr. Gupta observed. She often explains the mechanism of action of MIEBO to patients in terms of its ability to effectively coat and restore the ocular surface since this tends to make intuitive sense and can be validated quickly following instillation due to its smooth texture.
Understanding the molecule behind MIEBO
MIEBO is composed of a semifluorinated alkane that is dual-sided, with an aerophilic and lipophilic end, allowing it to bind to the lipids in the tear film while simultaneously creating a monolayer at the air-liquid interface. Conversely, artificial tears tend to dissipate after blinking, meaning that the active ingredient often has a much shorter residence time to work on the ocular surface.
Dr. Nichols remarked that in speaking with the developers of MIEBO, she learned that the semifluorinated alkane creates an aligned structure on the tear/air interface, which is critical for dry eye patients who have a rapid tear breakup time (TBUT) with “islands” of dryness that are indicative of an unstable tear film.
Due to its novel formula, MIEBO can possibly fill in these dry gaps, and after blinking, the tear film shifts but eventually settles again to stabilize the tear film for up to 6 hours. Although further studies are required to investigate these physical properties, she added that occasionally, the molecule may be able to penetrate the base layer of tears.
This unique molecular characteristic has been challenging to evaluate in existing studies as they predominantly use interferometry and is even more difficult because MIEBO has the same refractive index as water.
Identifying optimal candidates for MIEBO
Due to the broad indication of MIEBO, Dr. Nichols emphasized that it could be prescribed for a variety of patients and complementary to certain techniques. For example, MIEBO could be prescribed as a primary treatment or an extender treatment following an in-office procedure, such as intense pulsed light (IPL).
Ideal patients for MIEBO would likely be similar to the participants in the clinical trials who exhibited pre-existing corneal staining and some degree of MGD. Additionally, for patients who are unable to pursue or are uninterested in in-office procedures, this drop may be an entryway therapeutic to begin addressing the evaporative component of their DED.
Further, patients who have experienced adverse events with more traditional topical medications could be good candidates for MIEBO as the formula and mechanism of action differ significantly. There is also the opportunity to prescribe MIEBO concurrently with other medications for patients with significant mixed-mechanism dry eye.
Could MIEBO be prescribed for patients prior to cataract surgery?
MIEBO also has the potential to aid in optimizing the ocular surface prior to cataract surgery. Using the American Society of Cataract and Refractive Surgeons (ASCRS) Pre-operative Ocular Surface Disease (OSD) Algorithm, this topical ophthalmic formulation could fit into this scenario to help clinicians prepare patients for cataract surgery.
Simultaneously, there are still many details to investigate, such as understanding how MIEBO impacts biometry and how soon the drops need to be stopped to get an accurate understanding of the health of the patient’s ocular surface.
Dr. Gupta observed that she is waiting for further evidence on the safety and efficacy of MIEBO in pre-cataract surgery patients, and she will be very interested in reviewing the data. She also noted that it is very important to treat all corneal staining prior to cataract surgery as well as after cataract surgery.
Another potential patient population could be those who, following surgery, have finished a course of post-operative drops and have persistent dry eye. MIEBO has an excellent tolerability profile, which may be rather beneficial to patients who have difficulty with compliance due to burning and stinging.
What about prescribing MIEBO for MGD patients?
Dr. Gupta explained that another group of patients that could benefit from MIEBO are those with MGD. In her professional opinion, many dry eye patients who present to her clinic use artificial tears multiple times a day and may be prescribed additional therapies, such as an immunomodulator, nasal spray, or in-office procedure, but are still experiencing dry eye symptoms.
Instead of adding to the patient’s existing polypharmacy, Dr. Gupta often recommends switching out the artificial tear for MIEBO since it is FDA-approved to be administered one drop into each eye four times a day. Consequently, the patient does not have to change their existing regimen drastically—it is simply a replacement that might allow them to experience significant symptom relief due to its 6-hour retention time.
As more studies with MIEBO are completed, clinicians will have more data to understand MIEBO’s efficacy for patients with milder dry eye who potentially only require two drops a day and contact lens wearers with MGD.
Conclusion
Considering that the ocular surface is a complex ecosystem with various intrinsic and extrinsic moving parts, a new prescription therapy that stabilizes the tear film is a welcomed addition to the dry eye treatment arsenal. With ongoing studies, clinicians can interpret data for more potential applications of this novel molecule.
Lastly, Dr. Nichols noted a support service in collaboration with BlinkRx or a coupon card called “MySavings Program” for MIEBO that may allow commercially insured patients to pay as little as $0 for the copay of their initial prescription for MIEBO.
