Nearly 2 years after the FDA first approved Bausch + Lomb’s MIEBO (perfluorohexyloctane ophthalmic solution) for dry eye disease (DED), newly-published phase 4 data is detailing early patient-reported symptom relief following initial use.
The findings were published in Ophthalmology and Therapy late last month.
First up: a quick MIEBO refresh.
What it is: A proprietary, water-free, non-steroidal, single-component, and preservative-free eye drop formulated with 100% perfluorohexyloctane.
Its purpose: To treat the signs and symptoms of DED in patients aged 18+.
- Click here for its mechanism of action (MOA) and here for its prescribing information.
The dosing schedule: One prescription-based drop administered four times a day (QID) into the affected eye(s).
And when was it commercially launched?
The solution made its U.S. market debut in September 2023.
Now to its clinical performance. What did previous data indicate?
Positive findings, as evidenced by the eye drop’s approval. But to be more specific, MIEBO was evaluated in two phase 3 pivotal trials—GOBI (NCT04139798) and MOJAVE (NCT04567329)—in which participants included patients with a history of DED and clinical signs of meibomian gland dysfunction (MGD).
Both 57-day studies met their primary sign and symptom efficacy endpoints:
- Change from baseline at week 8 (day 57 ± 2) in total corneal fluorescein staining (tCFS)
- Eye dryness Visual Analog Scale (VAS) score
See here for detailed findings from the MOJAVE trial.
Any other findings following these two studies?
Just one! The KALAHARI phase 3 extension trial (NCT04140227) went on to evaluate MIEBO’s long-term safety and efficiency, with its findings published in November 2023—6 months after the drop’s FDA approval.
The data from that: Patients showed sustained efficacy throughout the study’s duration, with MIEBO continuing to improve tCS and eye dryness (as observed in the previous phase 3 trials).
- See here for our coverage, including specifics on those improved and sustained outcomes.
Alrighty, now let’s talk phase 4 data.
We’ll start with the basics of this study (NCT06309953)
- The design: prospective, open-label, multicenter
- The participants: 99 patients (aged 35-81) with a self-reported history of DED for ≥ 6 months (see here and here for full criteria)
- The setup: Participants instilled one MIEBO drop in both eyes QID (as recommended in its PI)
- The duration: 14 days
- The outcome measure: Mean change from baseline in dry eye symptoms severity at Visit 3 (see here for secondary endpoints)
- Time frame: Day 7 ± 1 day
How were patient-reported outcomes tracked?
Via surveys. To begin: Participants completed an early outcomes survey to log their self-reported symptom severity—identifying their most bothersome symptom—and frequency, as well as DED treatment satisfaction.
Surveys were then completed on the following days and times:
- Day 1 (predose [baseline], then at 5 minutes and 60 minutes post-first dose)
- Days 3, 7, and 14 (within 30 minutes to 4 hours post-dose)
And what did these surveys ask?
Among other information:
- Patients’ most bothersome symptom at baseline
- Rating severity of their overall dry eye symptoms
- Symptom frequency (at all timepoints except on day 1)
- Rating eight specific DED symptoms (based on Visual Analog Scale [VAS; 0 to 100])
- Eye dryness, itching, tiredness, irritation, pain, burning/stinging, blurred vision, and light sensitivity
- Treatment satisfaction (based on VAS)
Now to the findings.
To start: The most bothersome symptoms reported by patients at baseline were:
- Eye dryness (28.3% of patients)
- Blurred vision (17.2% of patients)
- Eye irritation (14.1% of patients)
- Light sensitivity (13.1% of patients)
- Eye tiredness (12.1% of patients)
- burning/stinging (11.1% of patients)
- Eye itching (4% of patients)
- Eye pain (0% of patients)
And how was symptom relief post-dosings?
Focusing on eye dryness: The mean frequency (percentage of time) experiencing this symptom decreased significantly over the 14-day period:
- Baseline: 77.9%
- Day 3: 46.7%
- Day 7: 41.3%
- Day 14: 34.7%
In general: Significant symptom relief was noted within 5 and 60 minutes of the first dose on day 1.
- The numbers: Mean scores on the VAS for overall dry eye symptoms were:
- 72.1 (17.0) at baseline
- 38.5 (22.8) at 5 min post-dose
- 31.7 (22.1) at 60 min post-dose
So … did the study meet its primary objective?
Yup. With treatment compliance between 90% and 120% for nearly all participants, MIEBO was reported to "significantly reduce overall symptom severity” by day 7 (meeting the primary endpoint).
- The numbers: Mean overall symptom severity (determined via VAS )decreased significantly from 72.1 (17.0) at baseline to 27.8 (22.3) at day 7 (mean change, − 44.5).
Notably: Investigators reported a “similar pattern in (symptom) severity reduction was observed for each individual dry eye symptom,” ranging from the following at 5 minutes post-instillation:
- 27% to 53% (day 1)
- 50% to 69% (day 3)
- 59% to 71% (day 7)
- 62% to 75% (day 14)
How were patients’ satisfaction with the drops?
Overall, their satisfaction ratings “increased steadily” over the study duration, from 83 on day 3 to 90 by day 14.
Along those lines: MIEBO was deemed to be “well tolerated,” with zero reports of any treatment-related adverse events.
Nice! But I have to ask: Were there any limitations with this study?
While the study authors noted the study’s strength in having each patient identify their most bothersome symptom—“which provided an individualized assessment of treatment effectiveness,” they stated—a few limitations were also called out.
Among them:
- The study’s open-label design
- Absence of a control group
- Lack of DED clinical signs assessment
- Limited participant diversity
And their final conclusions?
Per the authors: The study determined that DED participants “experienced significant and meaningful reductions in the severity and frequency of dry eye symptoms within the first 2 weeks of (MIEBO) treatment.”
And B+L’s Andrew Stewart, president, Global Pharmaceuticals and International Consumer, added: “These study results build on an impressive data set showing MIEBO as a well-tolerated and effective treatment option for dry eye disease that also can deliver much-needed, fast-acting symptom relief.”