Efficacy results across 2 pivotal studies1-3

100% of patients had clinical signs of meibomian gland dysfunction (MGD) at enrollment1-3

SIGN IMPROVEMENT AND SYMPTOM RELIEF

Total Corneal
Fluorescein Staining

PRIMARY ENDPOINT

Rapid and sustained improvement in TOTAL corneal fluorescein staining as early as Day 15 through Day 571,4

Total Corneal Fluorescein Staining (tCFS)2-4

Total corneal fluorescein staining chart Total corneal fluorescein staining chart
32% IMPROVEMENT from baseline in tCFS at Day 57 (control, 16%)[2-4]

Pooled analysis (above): Mean baseline tCFS = 6.9 for MIEBO and saline (control). tCFS grading scale: 0-15 (0-3 in each of 5 areas). Across GOBI and MOJAVE, 614 patients received MIEBO and 603 patients received control with 591 and 575, respectively, assessed on Day 57.2-4

INDIVIDUAL STUDY DATA1-3

GOBI: Mean (SD) CFB –2.0 (2.6) for MIEBO (n = 289) vs –1.0 (2.7) for control (n = 279) (P<0.001) at Day 57.

MOJAVE: Mean (SD) CFB –2.3 (2.8) for MIEBO (n = 302) vs –1.1 (2.9) for control (n = 296) (P<0.001) at Day 57.

CFB, change from baseline; SD, standard deviation.

Eye Dryness

PRIMARY ENDPOINT

Rapid and sustained relief of EYE DRYNESS as early as Day 15 through Day 571,4

Eye Dryness Score (Visual Analog Scale)2-4

Eye dryness chart Eye dryness chart
43% IMPROVEMENT from baseline in eye dryness at Day 57 (control, 29%)[2-4]

Pooled analysis (above): Mean baseline eye dryness score = 65.6 for MIEBO, 65.5 for saline (control). Eye dryness Visual Analog Scale (VAS): 0-100 (0 = no discomfort, 100 = maximal discomfort). Across GOBI and MOJAVE, 614 patients received MIEBO and 603 patients received control with 591 and 575, respectively, assessed on Day 57.2-4

INDIVIDUAL STUDY DATA1-3

GOBI: Mean (SD) CFB –27.4 (27.9) for MIEBO (n = 289) vs –19.7 (26.7) for control (n = 279) (P<0.001) at Day 57.

MOJAVE: Mean (SD) CFB –29.5 (28.6) for MIEBO (n = 302) vs –19.0 (27.2) for control (n = 296) (P<0.001) at Day 57.

Central Corneal Fluorescein Staining

SECONDARY ENDPOINT

Significant improvements in CENTRAL corneal fluorescein staining at Day 574

Central Corneal Fluorescein Staining (cCFS)4

Central corneal fluorescein staining chart Central corneal fluorescein staining chart
36% IMPROVEMENT from baseline in cCFS at Day 57 (control, 9%)[2-4]

Pooled analysis (above): Mean baseline cCFS = 1.1 for MIEBO and saline (control). cCFS grading scale: 0-3. Across GOBI and MOJAVE, 614 patients received MIEBO and 603 patients received control with 591 and 575, respectively, assessed on Day 57.2-4

INDIVIDUAL STUDY DATA2-4

GOBI: Mean (SD) CFB –0.4 (0.8) for MIEBO (n = 289) vs –0.1 (0.9) for control (n = 279) (P<0.001) at Day 57.

MOJAVE: Mean (SD) CFB –0.4 (0.8) for MIEBO (n = 302) vs –0.1 (0.9) for control (n = 296) (P<0.001) at Day 57.

Using corneal fluorescein staining in your practice can help assess damage caused by DED5

LEARN MORE

GOBI and MOJAVE study design—100% of
patients had evidence of evaporative DED1-3

MIEBO is the only approved Rx eye drop studied exclusively in patients with evidence of evaporative DED—including MGD score of ≥3 and TFBUT ≤5 seconds at enrollment1-3

Two 57-day, multicenter, double-masked, saline-controlled studies (GOBI and MOJAVE) were conducted in adults ≥18 years old with a self-reported history of DED in both eyes. Primary outcomes were change from baseline in tCFS and change from baseline in eye dryness score (Visual Analog Scale) at Day 57. Day 15 was the earliest time point at which signs and symptoms were evaluated in the trials. Day 57 was the last.

See the full study design

See data from our phase 4 study

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The KALAHARI 1-year safety and tolerability extension study7

Go to primary endpoint safety data

Demonstrated efficacy and excellent safety profile over 1 year, reinforcing results from MIEBO pivotal trials7

Patients in the MIEBO continuation group maintained the improvements in tCFS and eye dryness scores that were observed in the GOBI study

Patients in the saline crossover group demonstrated improvements in tCFS and eye dryness by Week 4 of KALAHARI, and results were maintained through Week 52

Total Corneal
Fluorescein Staining

EFFICACY ENDPOINT

Improvements in tCFS were maintained through Week 527

Total Corneal Fluorescein Staining

Total corneal fluorescein staining chart Total corneal fluorescein staining chart

Eye Dryness

EFFICACY ENDPOINT

Improvements in eye dryness were consistently maintained through Week 527

VAS Eye Dryness Score

Total corneal fluorescein staining chart Total corneal fluorescein staining chart

Day 1 = GOBI Visit 4 (Day 57) and KALAHARI Visit 1 (start of open-label MIEBO treatment) for those who enrolled in KALAHARI.7

QID, 4 times daily; SEM, standard error of the mean.

In KALAHARI, MIEBO demonstrated a favorable safety and tolerability profile while maintaining efficacy results consistent with the phase 3 GOBI study.7

KALAHARI study design7

208 patients from the GOBI study continued into KALAHARI and received MIEBO QID for 52 weeks7

KALAHARI was a 52-week, multicenter, single-arm, open-label extension study in adults ≥18 years old who completed the GOBI study. The primary safety endpoint was the occurrence of ocular and non-ocular adverse events (AEs). Efficacy endpoints included change from GOBI study baseline in tCFS and eye dryness score.

See the full study design
Study design diagram Study
  • Baseline ocular characteristics for patients included in KALAHARI were similar between patients assigned to MIEBO or hypotonic saline control in the GOBI study
  • Overall, 14 (6.7%) patients took ≥1 concomitant ocular medication (either eye) during the KALAHARI study. Ten patients (4.8%) used adjunctive artificial tears/mineral oil, as permitted, after Week 4
  • Most patients (93.8%) were considered compliant with dosing

Select outcome measures

SAFETY
Primary
  • Occurrence of ocular and non-ocular AEs over 52 weeks
Secondary
  • Best-corrected visual acuity (BCVA)
  • Slit-lamp biomicroscopy
  • Intraocular pressure (IOP)
  • Dilated fundoscopy
EFFICACY
  • Change from baseline in tCFS and eye dryness score at Week 52*
OTHER ENDPOINTS
  • Satisfaction with MIEBO, comfort of drop on instillation, and ease of administration (VAS, scale of 0 to 10)

OSDI, Ocular Surface Disease Index; QID, 4 times daily; TFBUT, tear film breakup time.

*National Eye Institute (NEI) scale: 0-3; tCFS: sum of NEI scale ratings for 5 corneal areas (0-15); eye dryness VAS: 0-100.

Study limitations include open-label design, lack of a control group, and exclusion of patients with severe dry eye (tCFS >11).

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Early effects of MIEBO on patient-
reported outcomes in DED:

a phase 4, prospective, open-label,
multicenter, single-arm study8

Relief in as fast as 5 minutes with continued
improvement through Day 148

 

Visual Analog Scale Score

PRIMARY ENDPOINT

Relief in as fast as 5 minutes with reduced symptoms at every time point8

Patient-reported severity of overall dry eye symptoms

Total corneal fluorescein staining chart Total corneal fluorescein staining chart

BL, baseline; CFB, change from baseline; SD, standard deviation.
During the 14-day study, MIEBO was dosed QID per label.
Data missing for 1 patient at Day 1 (60 minutes post-dose assessment; item left blank) and 1 patient at Days 7 and 14 (due to study discontinuation).

Patients rated the severity of overall dry eye symptoms on a VAS from 0 (none) to 100 (worst severity possible). Mean (SD) VAS ratings of symptom severity were 72.1 (17.0) at baseline, 38.5 (22.5) at 5 minutes post-instillation on Day 1, 31.7 (22.1) at 60 minutes post-instillation on Day 1, 33.2 (25.1) at Day 3, 27.8 (22.3) at Day 7, and 24.7 (23.0) at Day 14. P<0.0001 vs baseline (paired t test).

Significant reductions in 8 leading symptoms8

Patients rated the severity of the 8 symptoms on a VAS from 0 (none) to 100 (worst severity possible). Across symptoms, percent reduction from baseline severity ranged from 27%-53% at 5 minutes post-instillation on Day 1, 50%-69% at 60 minutes post-instillation on Day 1, 50%-59% at Day 3, 59%-71% at Day 7, and 62%-75% at Day 14. P<0.0001 vs baseline (paired t test) on all item scores at all time points.

32% IMPROVEMENT from baseline in tCFS at Day 57 (control, 16%)[2-4]

Pooled analysis (above): Mean baseline tCFS = 6.9 for MIEBO and saline (control). tCFS grading scale: 0-15 (0-3 in each of 5 areas). Across GOBI and MOJAVE, 614 patients received MIEBO and 603 patients received control with 591 and 575, respectively, assessed on Day 57.2-4

INDIVIDUAL STUDY DATA1-3

GOBI: Mean (SD) CFB –2.0 (2.6) for MIEBO (n = 289) vs –1.0 (2.7) for control (n = 279) (P<0.001) at Day 57.

MOJAVE: Mean (SD) CFB –2.3 (2.8) for MIEBO (n = 302) vs –1.1 (2.9) for control (n = 296) (P<0.001) at Day 57.

CFB, change from baseline; SD, standard deviation.

Visual Analog Scale Score

SECONDARY ENDPOINT

Significant reductions in symptom frequency8

Patient-reported fluctuations in vision quality

Error bars represent standard deviation. Data missing for 1 patient on Days 7 and 14 (due to study discontinuation).

Symptom frequency was assessed (at all time points except post-instillation on Day 1) as the percentage of time that patients experienced their most bothersome symptom, awareness of symptoms, and fluctuations in quality of vision, each rated on a VAS from 0% (never) to 100% (all the time). Mean frequency experiencing the most bothersome symptom decreased significantly from 77.9% at baseline to 46.7% at Day 3, 41.3% at Day 7, and 34.7% at Day 14. Significant decreases were also observed in mean frequency of awareness of symptoms (77.6% at baseline, 39.7% at Day 3, 32.6% at Day 7, and 27.6% at Day 14) and fluctuations in quality of vision. All P<0.0001 vs baseline (paired t test).

43% IMPROVEMENT from baseline in eye dryness at Day 57 (control, 29%)[2-4]

Pooled analysis (above): Mean baseline eye dryness score = 65.6 for MIEBO, 65.5 for saline (control). Eye dryness Visual Analog Scale (VAS): 0-100 (0 = no discomfort, 100 = maximal discomfort). Across GOBI and MOJAVE, 614 patients received MIEBO and 603 patients received control with 591 and 575, respectively, assessed on Day 57.2-4

INDIVIDUAL STUDY DATA1-3

GOBI: Mean (SD) CFB –27.4 (27.9) for MIEBO (n = 289) vs –19.7 (26.7) for saline (n = 279) (P<0.001) at Day 57.

MOJAVE: Mean (SD) CFB –29.5 (28.6) for MIEBO (n = 302) vs –19.0 (27.2) for saline (n = 296) (P<0.001) at Day 57.

OSDI Scores

SECONDARY ENDPOINT

Significant reduction in OSDI scores8

~64%

IMPROVEMENT

in total OSDI score from baseline

Mean total
OSDI score

IMPROVED FROM
SEVERE TO MILD

by Day 14

  • Significant mean change from baseline (SD) in total OSDI score was -32.1 (18.1), P<0.0001
    • Minimal clinically important difference in mild DED is 5-7 and 7-13 for severe DED6
  • Mean total OSDI score started as severe (~51) at baseline and at Day 14 was reported as mild (~18)
    • Normal (0-12), mild (13-22), moderate (23-32), severe (33-100)6
  • Improvements in subscores of ocular symptoms, vision-related function, and environmental triggers at Day 14 compared to baseline

The OSDI is a 12-item questionnaire with 3 components: symptom severity, impact on daily activities, and environmental triggers. The total OSDI score was calculated as [(sum of all item scores) x25] / # of items answered; each item scored from 0-4; possible score range, 0-100. Ocular symptom subtotal: each item scored from 0-4; possible score range 0-20. Vision-related function subtotal: each item scored from 0-4; possible score range, 0-16. Environmental triggers subtotal: each item scored from 0-4; possible score range 0-12.

36% IMPROVEMENT from baseline in cCFS at Day 57 (control, 9%)[2-4]

Pooled analysis (above): Mean baseline cCFS = 1.1 for MIEBO and saline (control). cCFS grading scale: 0-3. Across GOBI and MOJAVE, 614 patients received MIEBO and 603 patients received control with 591 and 575, respectively, assessed on Day 57.2-4

INDIVIDUAL STUDY DATA2-4

GOBI: Mean (SD) CFB –0.4 (0.8) for MIEBO (n = 289) vs –0.1 (0.9) for saline (n = 279) (P<0.001) at Day 57.

MOJAVE: Mean (SD) CFB –0.4 (0.8) for MIEBO (n = 302) vs –0.1 (0.9) for saline (n = 296) (P<0.001) at Day 57.

PHASE 4 STUDY DESIGN8

Inclusion criteria, dosing frequency, and analyzed symptom outcomes are consistent with those studied in the MIEBO pivotal clinical trials8

An early outcomes survey assessed DED symptoms (severity and frequency; clinical signs were not assessed in this study) and treatment satisfaction using a VAS (0-100). Adults aged ≥18 years with a self-reported history of bilateral DED and clinical signs of meibomian gland dysfunction (score ≥3 on a 0-15 scale) were included. Study participants completed early outcomes surveys on Day 1 (pre-dose [baseline] and at 5 minutes and 60 minutes after the first instillation of MIEBO) and on Days 3, 7, and 14 (within 30 minutes to 4 hours post-dose).

Study limitations include open-label design, lack of a control group, lack of assessment of clinical signs of DED (eg, corneal fluorescein staining score), and limited diversity of the study population. Data should be interpreted with the study design and these limitations in mind. No formal conclusions should be drawn.

See the full study design
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See the impact of MIEBO on corneal fluorescein staining2-4

SEE STAINING
IN ACTION

WATCH VIDEO

Corneal fluorescein staining can evaluate ocular surface damage, aid with diagnosis, help identify appropriate treatment, and monitor response.5

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By submitting your information, you consent to receive communications containing information and educational resources about MIEBO, as well as other communications from Bausch + Lomb. By submitting your information, you confirm that you have read and agree with the terms of our Privacy Policy and Legal Notice.

INDICATION

MIEBO® (perfluorohexyloctane ophthalmic solution) is indicated for the treatment of the signs and symptoms of dry eye disease.

IMPORTANT SAFETY INFORMATION

  • 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
  • The most common ocular adverse reaction was blurred vision (1% to 3% of patients reported blurred vision and conjunctival redness)

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.

Click here for full Prescribing Information for MIEBO.

References: 1. MIEBO. Prescribing Information. Bausch & Lomb, Inc. 2. Tauber J, Berdy GJ, Wirta DL, Krösser S, Vittitow JL; GOBI Study Group. NOV03 for dry eye disease associated with meibomian gland dysfunction: results of the randomized phase 3 GOBI study. Ophthalmology. 2023;130(5):516-524. doi:10.1016/j.ophtha.2022.12.021 3. Sheppard JD, Kurata F, Epitropoulos AT, Krösser S, Vittitow JL; MOJAVE Study Group. NOV03 for signs and symptoms of dry eye disease associated with meibomian gland dysfunction: the randomized phase 3 MOJAVE study. Am J Ophthalmol. 2023;252:265-274. doi:10.1016/j.ajo.2023.03.008 4. Data on file. Bausch & Lomb, Inc. 5. Sall K, Foulks GN, Pucker AD, Ice KL, Zink RC, Magrath G. Validation of a modified National Eye Institute grading scale for corneal fluorescein staining. Clin Ophthalmol. 2023;17:757-767. doi:10.2147/OPTH.S398843 6. Miller KL, Walt JG, Mink DR, et al. Minimal clinically important difference for the ocular surface disease index. Arch Ophthalmol. 2010;128(1):94-101. doi:10.1001/archophthalmol.2009.356 7. Protzko EE, Segal BA, Korenfeld MS, Krösser S, Vittitow JL. Long-term safety and efficacy of perfluorohexyloctane ophthalmic solution for the treatment of patients with dry eye disease: the KALAHARI study. Cornea. 2024;43(9):1100-1107. doi:10.1097/ICO.0000000000003418 8. Bacharach J, Kannarr SR, Verachtert A, et al. Early effects of perfluorohexyloctane ophthalmic solution on patient-reported outcomes in dry eye disease: a prospective, open-label, multicenter study. Ophthalmol Ther. 2025;14(4):693-704. doi:10.1007/s40123-025-01097-z

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INDICATION AND IMPORTANT
SAFETY INFORMATION

INDICATION

MIEBO® (perfluorohexyloctane ophthalmic solution) is indicated for the treatment of the signs and symptoms of dry eye disease.

IMPORTANT SAFETY INFORMATION

  • 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
  • The most common ocular adverse reaction was blurred vision (1% to 3% of patients reported blurred vision and conjunctival redness)

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.

Click here for full Prescribing Information for MIEBO.