On this episode of Interventional Mindset, Preeya K. Gupta, MD, sits down with Eric Mann, MD, to discuss how to effectively manage evaporative dry eye disease (DED) to improve patient outcomes and new phase 4 data on MIEBO (perfluorohexyloctane ophthalmic solution, Bausch + Lomb).
Dr. Mann is a comprehensive ophthalmologist and owner of Eye Associates of North Jersey in Dover, New Jersey.
Dry eye disease classification and prevalence
The current understanding of dry eye outlines two general etiological subtypes:1-3
- Aqueous-deficient dry eye: Diminished lacrimal output causes a higher concentration of salts, ions, proteins, and other components in the tear film, which leads to tear film hyperosmolarity
- Evaporative dry eye: Typically features near-normal tear secretions from the lacrimal gland; however, excessive evaporation from the ocular surface (ex., meibomian gland dysfunction [MGD]) results in tear film hyperosmolarity
Moreover, studies have found that around 50% of individuals with DED had only MGD as an etiological factor, 14% were attributed to purely aqueous-deficient dry eye, and the remaining 36% had mixed-mechanism dry eye.2,4 As such, knowing how to identify and manage evaporative dry eye is critical to recommending targeted dry eye treatments that address the correct etiology.
Identifying patients with evaporative dry eye in a busy practice
Dr. Mann noted that a thorough history is helpful for identifying patients with evaporative dry eye. He recalled that a mentor during training told him, “If you just shut up and listen, your patient will tell you exactly what is wrong with them.”
Consequently, while taking the patient history, he asks patients to describe the onset of symptoms, what activities they are doing when the symptoms occur, and what the symptoms feel like.
He added that patients with evaporative dry eye often describe having fluctuating and blurred vision, so once he hears this, he relies on two key practical diagnostic tools:
- Tear breakup time (TBUT) at the slit lamp to observe how the tear film is evaporating on their eye
- Assessing the meibomian glands and checking the composition of the meibum by performing a push test on the lids
To hear Dr. Gupta’s favorite question to ask patients with evaporative dry eye, watch the full interview!
Managing evaporative dry eye in an ophthalmology practice
Once he has confirmed that a patient has evaporative dry eye, Dr. Mann considers the full spectrum of treatments, including:
- Lifestyle modifications
- Blink exercises when in front of a computer screen, like the 20 for 20 rule, wherein every 20 minutes of consistent visual concentration requires 20 strong, exaggerated blinks
- Diet and omega-3 supplementation
- Drops and tear lubrication, especially those that stay on the ocular surface for longer periods of time
- Bruder Moist Heat Eye Compresses (Bruder Healthcare)
- In-office treatments for MGD such as:
- Intense pulsed light (IPL)
- Radiofrequency (RF)
- TearCare (Sight Sciences)
- Lipiflow (Johnson & Johnson Vision)
Dr. Gupta noted that her two main approaches to treating evaporative dry eye are pharmacologic therapies and interventional office-based procedures. MIEBO has changed how she manages these patients, in part because it has been shown to stay on the ocular surface for up to 6 hours.5,6 She has also found it to be a great adjunctive therapy with in-office treatments to help with maintaining and improving the flow of meibum.
Overview of MIEBO
MIEBO's active ingredient—perfluorohexyloctane (PFHO)—is a semifluorinated alkane that forms a monomolecular layer for the tear film, acting as a physical barrier that reduces tear evaporation and friction during blinking, which may protect corneal epithelial cells and support overall ocular surface healing.7-10
Of note, MIEBO was approved by the FDA in May 2023 for the treatment of the signs and symptoms of DED, with a recommended dosage of one drop in each affected eye four times a day.
Three key clinical trials have demonstrated the safety and efficacy of MIEBO, including:11
- GOBI (NCT04139798)8
- Key findings:
- At Week 8, PFHO significantly improved total corneal fluorescein staining (tCFS, P < 0.001) and eye dryness score (P < 0.001), demonstrating its effectiveness in reducing ocular surface damage and discomfort
- Safety profile:
- Most adverse events (AEs) were mild or transient, with no serious treatment-related AEs
- Ocular AEs occurred in 9.6% (PFHO) vs. 7.5% (saline), with blurred vision (3.0%) as the most common
- Only one patient discontinued due to eye irritation
- Key findings:
- MOJAVE (NCT04567329)9
- Key findings:
- At Week 8, PFHO significantly improved both signs and symptoms of DED, with a least-squares (LS) mean reduction in tCFS of 2.3 (vs. 1.1 in the saline group) and a LS mean reduction in eye dryness score (Visual Analog Scale [VAS]) of 29.4 (vs. 19.2 in the saline group)
- Notably, significant improvements in both tCFS and eye dryness were observed as early as Week 2
- Safety profile:
- Most AEs were mild or transient, with no serious treatment-related AEs reported
- Ocular AEs occurred in 12.9% of PFHO-treated patients vs. 12.3% in the saline group
- Key findings:
- KALAHARI (open-label extension of GOBI, NCT04140227)10
- Key findings:
- Subjects continuing PFHO from GOBI maintained significant reductions in tCFS and dryness scores (VAS) through Week 52
- Those switched from hypotonic saline to PFH experienced rapid improvement by Week 4, sustained for the remainder of the study
- Safety:
- In total, 12% of participants reported ≥ 1 ocular AE, with mild severity in most cases
- The most frequent AEs were allergic conjunctivitis (1.4%) and blurred vision (1.4%)
- No serious treatment-related AEs were recorded, reinforcing PFHO’s suitability for extended therapy
- Key findings:
New phase 4 data on MIEBO
Recently, phase 4 data were published in Ophthalmology and Therapy and presented at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting.12,13 The prospective, multicenter, open-label phase 4 study enrolled 99 patients (85.9% female, age range: 35-81) with a history of DED for ≥6 months and tracked patient-reported outcomes with surveys for 14 days.13
The surveys were completed on Days 1, 3, 7, and 14, and covered information about:12,13
- Patients’ most bothersome symptom at baseline
- Rating the severity of their overall dry eye symptoms
- Symptom frequency (at all timepoints except on Day 1)
- Rating eight specific DED symptoms (based on VAS)
- Eye dryness, itching, tiredness, irritation, pain, burning/stinging, blurred vision, and light sensitivity
- Treatment satisfaction (based on VAS)
Key findings from the study include:13
- The three most bothersome symptoms reported at baseline were eye dryness (28.3%), blurred vision (17.2%), and eye irritation (14.1%)
- Significant symptom relief was noted within 5 and 60 minutes of the first dose on Day 1
- The primary endpoint was met, as mean overall symptom severity decreased significantly from 72.1 at baseline to 27.8 at Day 7 (mean change: -44.5, P < 0.001)
- The mean percentage of time experiencing the most bothersome symptom decreased from 77.9% at baseline to 34.7% at Day 14
- Significant reductions in severity and frequency were also observed for all symptoms at all post-baseline assessments (P < 0.001)
- The median ratings of treatment satisfaction were 83.0 at Day 3, 86.0 at Day 7, and 90.0 at Day 14
Drs. Gupta and Mann highlighted how excited they were after hearing that patients reported improvements in symptoms only 5 minutes after instillation.13 There are few drops where patients experience results that quickly, which can help with sustaining motivation to adhere to treatment regimens, added Dr. Mann.
Conclusion
Considering the widespread prevalence of evaporative dry eye, having a targeted pharmacologic therapy that directly addresses the root cause and can improve symptoms in as fast as 5 minutes, makes MIEBO a welcome addition to any ophthalmologist's armamentarium.
