Drug Trials Snapshot: MIEBO
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.
Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the MIEBO Prescribing Information for all the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).
Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).
MIEBO (perfluorohexyloctane ophthalmic solution)
Mye-EH-boh
Bausch & Lomb Incorporated
Original Approval date: May 18, 2023
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
MIEBO is a treatment for patients with the signs and symptoms of dry eye disease (DED). DED is a multi-factorial, age-related, chronic progressive disease of the ocular surface. Chronic DED can cause discomfort, visual impairment, tear film hyperosmolarity, and inflammation. Patients with DED are more susceptible than others to eye infections and damage to the surface of the eye (cornea).
How is this drug used?
MIEBO is an ophthalmic solution that is administered as an eye drop four times a day.
Who participated in the clinical trials?
The FDA approved MIEBO based on evidence from two clinical trials in 1,217 patients (MIEBO and saline control patient total) with DED. Trial NVU-003 (GOBI) was conducted at 26 sites in the United States. Trial BL-904 (MOJAVE) was conducted at 42 sites in the United States.
How were the trials designed?
MIEBO was evaluated for efficacy in two phase 3 clinical trials in 1,217 patients with signs and symptoms of dry eye disease.
How were the trials designed?
The two trials were randomized, saline-controlled, double-masked, parallel group trials in patients with signs (e.g., corneal staining score) and symptoms (e.g., eye dryness score) of dry eye disease. The trials consisted of five visits over a 10-week period.
DEMOGRAPHICS SNAPSHOT
Figure 1 summarizes how many male and female patients were enrolled in the combined clinical trials used to evaluate the efficacy of MIEBO.
Figure 1. Baseline Demographics by Sex
Source: Adapted from FDA Review
Figure 2 summarizes how many patients by race were in the combined trials used to evaluate the efficacy of MIEBO.
Figure 2. Baseline Demographics by Race
Source: Adapted from FDA Review
Figure 3 summarizes how many patients by age were in the combined trials used to evaluate the efficacy of MIEBO.
Figure 3. Baseline Demographics by Age
Source: Adapted from FDA Review
Figure 4 summarizes how many patients by ethnicity were in the combined trials used to evaluate the side effects of MIEBO.
Figure 4. Baseline Demographics by Ethnicity
Source: Adapted from FDA Review
Who participated in the trials?
The mean age of the study population in the trials (pivotal) was approximately 60 years (range: 19 to 88 years). Total subjects in pivotal efficacy trials were 1,217 subjects. There were no patients enrolled <18 years of age; roughly 37% of patients were ≥65 years. The majority of subjects were female (approximately 76%).
Table 1. Demographics, Pooled Trials
| Demographics | MIEBO N=614 |
Saline N=603 |
| Age, years | ||
| Mean (SD) | 56.8 (16.3) | 57.6 (15.5) |
| Median | 60.0 | 60.0 |
| Min, max | 19, 87 | 19, 88 |
| Age group, years, n (%) | ||
| ≥18 to <65 | 392 (63.8) | 375 (62.2) |
| ≥65 | 222 (36.2) | 228 (37.8) |
| Sex, n (%) | ||
| Male | 145 (23.6) | 151 (25.0) |
| Female | 469 (76.4) | 452 (75.0) |
| Race, n (%) | ||
| White | 456 (74.3) | 459 (76.1) |
| Black or African American | 76 (12.4) | 75 (12.4) |
| Asian | 70 (11.4) | 55 (9.1) |
| Other | 3 (0.5) | 6 (1.0) |
| Native Hawaiian or other Pacific Islander | 3 (0.5) | 3 (0.5) |
| Multiple | 3 (0.4) | 4 (0.7) |
| American Indian or Alaska Native | 3 (0.5) | 0 |
| Unknown | 0 | 1 (0.2) |
| Ethnicity, n (%) | ||
| Hispanic or Latino | 106 (17.3) | 116 (19.2) |
| Not Hispanic or Latino | 508 (82.7) | 487 (80.8) |
| Country, n (%) | ||
| United States | 614 (100) | 603 (100) |
Source: Adapted from FDA Review
Abbreviations: BID, two times a day; OD, right eye; OS, left eye; QID, four times a day; SD, standard deviation
What are the benefits of this drug?
After Day 57 of use, dry eye patients treated with MIEBO experienced improvement in their corneal surface and an improvement in their dryness symptom score.
What are the benefits of this drug (results of trials used to assess efficacy)?
MIEBO provides an alternate product for the treatment of dry eye disease. It prevents the evaporation of the aqueous (watery) tear film component. MIEBO is a clear and colorless liquid containing no water component and is meant for topical eye use. The two studies (MOJAVE and GOBI) were used to establish the efficacy of MIEBO dosed four times a day for the treatment of the signs and symptoms of DED. Both studies met their co-primary endpoints, change from baseline in temporal corneal fluorescein staining (“corneal smoothness”) and change in baseline in the eye dryness symptom score at Day 57.
Table 2. Mean Change (Standard Deviation) From Baseline and Treatment Difference (MIEBO-Saline) in Total Corneal Fluorescein Staining (Study Eye) in 8-Week Study in Patients With Dry Eye Disease
| Visit | GOBI | MOJAVE | ||||
| MIEBO N=303 |
Saline N=294 |
Difference (95% CI) |
MIEBO N=311 |
Saline N=309 |
Difference (95% CI) |
|
| Baseline | 6.7 (1.8) | 6.7 (1.9) | NA | 7.0 (2.0) | 7.1 (1.9) | NA |
| Day 15 | -1.7 (2.1) | -1.1 (2.2) | -0.58 (-0.93, -0.23) | -1.9 (2.3) | -1.3 (2.4) | -0.60 (-0.97, -0.24) |
| Day 57 | -2.0 (2.6) | -1.0 (2.7) | -0.97 (-1.40, -0.55) | -2.3 (2.8) | -1.1 (2.9) | -1.21 (-1.66, -0.76) |
Source: Adapted from MIEBO Prescribing Information
Abbreviations: CI, confidence interval; NA, not applicable
Table 3. Mean Change (Standard Deviation) From Baseline and Treatment Difference (MIEBO-Saline) in Eye Dryness Score (Study Eye) in 8-Week Study in Patients With Dry Eye Disease
| Visit | GOBI | MOJAVE | ||||
| MIEBO N=303 |
Saline N=294 |
Difference (95% CI) |
MIEBO N=311 |
Saline N=309 |
Difference (95% CI) |
|
| Baseline | 66.5 (19.1) | 66.8 (18.7) | NA | 64.7 (19.5) | 64.3 (19.8) | NA |
| Day 15 | -18.0 (24.0) | -13.4 (23.3) | -4.72 (-8.25, -1.20) | -18.5 (23.5) | -10.5 (23.9) | -7.79 (-11.28, -4.29) |
| Day 57 | -27.4 (27.9) | -19.7 (26.7) | -7.61 (-11.82, -3.40) | -29.5 (28.6) | -19.0 (27.2) | -10.24 (-14.35, -6.08) |
Source: Adapted from MIEBO Prescribing Information
Abbreviations: CI, confidence interval; NA, not applicable
Were there any differences in how well the drug worked in clinical trials among sex, race, and age?
Adult patients with DED regardless of race or sex were eligible to participate in the clinical studies. The study population was majority White, not of Hispanic origin, female, with an average age of 59 years. The studies did not demonstrate a difference in efficacy based on these demographic factors.
- Sex: MIEBO worked similarly in males and females.
- Race: MIEBO worked similarly in White, Black or African American, Asian, and other races.
- Age: MIEBO worked similarly in patients younger and older than 65 years of age.
Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?
Table 4 and Table 5 summarize GOBI and MOJAVE results for the primary efficacy endpoints by sex, age, and race group.
Table 4. Primary Endpoints Results in Study GOBI Subgroup Analysis
| Change From Baseline | tCFS (Study Eye) | Dryness Score (VAS) | ||||
| MIEBO, N=289 | Saline, N=279 | MIEBO - Saline LSMD (95% CI) | MIEBO, N=289 | Saline, N=279 | MIEBO - Saline LSMD (95% CI) | |
| n (%) Mean (SD) | n (%) Mean (SD) | n (%) Mean (SD) | n (%) Mean (SD) | |||
| Sex | ||||||
| Male | -2.2 (2.2) | -1.4 (2.2) | -0.5 (-1.3, 0.2) | -21.1 (23.6) | -19.9 (23.3) | -0.6 (-8.5, 7.3) |
| Female | -2.0 (2.7) | -0.9 (2.9) | -1.1 (-1.6, -0.6) | -29.6 (29.0) | -19.6 (28.0) | -9.6 (-14.9, -4.2) |
| Age, years | ||||||
| <65 | -2.3 (2.4) | -1.0 (2.9) | -1.2 (-1.8, -0.6) | -28.2 (27.8) | -17.5 (24.7) | -9.7 (-15.8, -3.7) |
| ≥65 | -1.7 (2.7) | -1.0 (2.5) | -0.8 (-1.4, -0.2) | -26.3 (28.1) | -21.9 (28.5) | -7.4 (-14.0, -0.7) |
| Race | ||||||
| White | -2.1 (2.5) | -1.1 (2.7) | -1.0 (-1.4, -0.5) | -29.4 (26.8) | -20.6 (27.7) | -8.7 (-14.0, -3.5) |
| Black or African American | -1.2 (2.5) | -0.9 (2.7) | -0.6 (-1.6, 0.4) | -22.7 (33.1) | -15.5 (24.4) | -2.4 (-13.5, 8.6) |
| Asian | -2.8 (2.5) | -0.4 (2.9) | -2.5 (-3.9, -1.2) | -21.5 (24.7) | -19.0 (25.4) | -3.3 (-16.4, 9.8) |
| Others | -2.3 (2.6) | -2.1 (1.1) | -* | -29.0 (36.0) | -26.3 (20.3) | -* |
Source: Adapted from FDA Review
*: not estimated because of few subjects in the category
Abbreviations: CI, confidence interval; LSMD, least square mean difference; SD, standard deviation; tCFS, total corneal fluorescein staining; VAS, visual analog scal
Table 5. Primary Endpoints Results in MOJAVE Subgroup Analysis
| Change From Baseline | tCFS (Study Eye) | Dryness Score (VAS) | ||||
| MIEBO, N=302 | Saline, N=296 | MIEBO - Saline LSMD (95% CI) | MIEBO, N=302 | Saline, N=296 | MIEBO - Saline LSMD (95% CI) | |
| n (%) Mean (SD) | n (%) Mean (SD) | n (%) Mean (SD) | n (%) Mean (SD) | |||
| Sex | ||||||
| Male | -2.3 (2.8) | -1.3 (2.3) | -0.7 (-1.6, 0.2) | -32.4 (25.0) | -21.5 (25.4) | -13.9 (-24.2, -3.7) |
| Female | -2.3 (2.8) | -1.1 (3.1) | -1.5 (-2.0, -1.0) | -28.8 (29.4) | -18.2 (27.8) | -9.4 (-14.3, -4.4) |
| Age, years | ||||||
| <65 | -2.6 (2.7) | -1.2 (2.9) | -1.5 (-2.0, -1.1) | -30.5 (27.1) | -18.7 (27.9) | -10.7 (-15.8, -5.6) |
| ≥65 | -1.8 (3.0) | -1.0 (3.0) | -1.0 (-1.9, -0.2) | -27.7 (31.5) | -19.7 (25.7) | -8.6 (-16.8, -0.4) |
| Race | ||||||
| White | -2.3 (2.9) | -1.1 (3.0) | -1.2 (-1.7, -0.8) | -29.1 (28.6) | -18.7 (27.8) | -10.7 (-15.6, -5.8) |
| Black or African American | -2.5 (2.1) | -2.6 (1.8) | -0.1 (-1.4, 1.3) | -26.7 (32.3) | -24.1 (29.0) | 4.7 (-15.8, 25.3) |
| Asian | -2.6 (2.8) | 0 (2.3) | -2.6 (-3.7, -1.5) | -33.1 (25.5) | -18.1 (25.0) | -10.2 (-22.8, 2.4) |
| Others | -3.0 (1.2) | -1.9 (3.3) | -* | -35.9 (32.2) | -18.3 (6.6) | -* |
Source: Adapted from FDA Review
*: not estimated because of few subjects in the category
Abbreviations: CI, confidence interval; LSMD, least square mean difference; SD, standard deviation; tCFS, total corneal fluorescein staining; VAS, visual analog scal
What are the possible side effects?
The most common side effects involving the eye was blurred vision. Blurred vision and conjunctival (“eye”) redness were reported in 1% to 3% of patients. The most common general side effect was headache reported in 1% of patients.
What are the possible side effects (results of trials used to assess safety)?
Table 6. Ocular Adverse Events Occurring in >1 Subject
| Preferred Term | MIEBO QID N=728 n (%) |
Saline N=714 n (%) |
| Vision blurred | 22 (3.0%) | 10 (1.4%) |
| Ocular hyperemia | 8 (1.1%) | 1 (0.1%) |
| Conjunctival hyperemia | 5 (0.7%) | 6 (0.8%) |
| Eye pruritus | 5 (0.7%) | 6 (0.8%) |
| Eye discharge | 5 (0.7%) | 4 (0.6%) |
| Instillation site pain | 5 (0.7%) | 3 (0.4%) |
| Blepharitis | 5 (0.7%) | 1 (0.1%) |
| Eye irritation | 4 (0.5%) | 3 (0.4%) |
| Conjunctival papillae | 4 (0.5%) | 5 (0.7%) |
| Foreign body sensation in eyes | 4 (0.5%) | 1 (0.1%) |
| Hordeolum | 4 (0.5%) | 3 (0.4%) |
| Lacrimation increased | 4 (0.5%) | 0 |
Source: Adapted from FDA Review
Abbreviations: QID, four times a day
Table 7. Non-Ocular Adverse Events Occurring in >1 Subject
| Preferred Term | MIEBO QID N=728 n (%) |
Saline N=714 n (%) |
| Headache | 8 (1.1%) | 10 (1.4%) |
| Pain | 6 (0.8%) | 1 (0.1%) |
| Nasopharyngitis | 5 (0.7%) | 2 (0.3%) |
| Sinusitis | 5 (0.7%) | 0 |
| Pyrexia | 4 (0.5%) | 3 (0.4%) |
Source: Adapted from FDA Review
Abbreviations: QID, four times a day
Were there any differences in side effects among sex, race, and age?
Adult patients with DED regardless of race or sex were eligible to participate in the clinical studies. The study population was majority White, not of Hispanic origin, female, with an average age of 59 years.
The studies did not demonstrate a difference in side effects based on these demographic factors.
- Sex: The occurrence of side effects was similar in males and females.
- Race: The occurrence of side effects was similar in White and Black or African American patients.
- Age: The occurrence of side effects was similar in patients younger and older than 65 years of age.
Were there any differences in side effects of the clinical trials among sex, race, and age groups?
Table 8. Overview of Adverse Events by Demographic Subgroup, Safety Population
| Characteristic | MIEBO BID N=111 n/Ns (%) |
MIEBO QID N=728 n/Ns (%) |
Saline N=714 n/Ns (%) |
| Sex | |||
| Female | 24/84 (28.6%) | 94/548 (17.2%) | 91/532 (17.1%) |
| Male | 3/27 (11.1%) | 34/180 (18.9%) | 22/182 (12.1%) |
| Age group, years | |||
| ≥18 to <65 | 19/82 (23.2%) | 79/456 (17.3%) | 74/437 (16.9%) |
| ≥65 | 8/29 (27.6%) | 49/272 (18.0%) | 39/277 (14.1%) |
| Race | |||
| American Indian or Alaska Native | 0/0 (NA) | 0/4 (0%) | 0/1 (0%) |
| Asian | 4/20 (20.0%) | 7/88 (8.0%) | 8/76 (10.5%) |
| Black or African American | 3/13 (23.1%) | 10/89 (11.2%) | 7/83 (8.4%) |
| Multiple | 0/0 (NA) | 1/3 (33.3%) | 2/4 (50.0%) |
| Native Hawaiian or other Pacific Islander | 0/0 (NA) | 1/5 (20.0%) | 0/3 (0%) |
| Other | 0/0 (NA) | 1/3 (33.3%) | 0/6 (0%) |
| Unknown | 0/0 (NA) | 0/0 (NA) | 0/1 (0%) |
| White | 20/78 (25.6%) | 108/536 (20.1%) | 96/540 (17.8%) |
| Ethnicity | |||
| Hispanic or Latino | 4/26 (15.4%) | 27/136 (19.9%) | 23/137 (16.8%) |
| Not Hispanic or Latino | 23/85 (27.1%) | 101/592 (17.1%) | 90/577 (15.6%) |
Source: Adapted from FDA Review
Abbreviations: BID, twice daily; CI, confidence interval; N, number of patients in treatment arm; n, number of patients with adverse event; NA, not applicable; Ns, total number of patients for each specific subgroup and were assigned to that specific arm; QID, four times a da
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.