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 chartTotal 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 chartEye 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 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.

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 chartCentral 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 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.

GOBI and MOJAVE study design

The only approved Rx eye drop that required all patients in pivotal studies to have clinical signs of MGD 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.1-3

See the full study design

The KALAHARI 1-year safety and tolerability extension study5

Go to primary endpoint safety data

Demonstrated efficacy and excellent safety profile over 1 year, reinforcing results from MIEBO pivotal trials5

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 525

Total Corneal Fluorescein Staining

Total corneal fluorescein staining chart

Eye Dryness

EFFICACY ENDPOINT

Improvements in eye dryness were consistently maintained through Week 525

VAS Eye Dryness Score

Eye dryness chart

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

QID, 4 times daily; SEM, standard error of the mean.5

In KALAHARI, MIEBO demonstrated a favorable safety and tolerability profile while maintaining efficacy results consistent with the phase 3 GOBI study.5

KALAHARI study design5

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

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 diagramStudy
  • Baseline ocular characteristics for patients included in KALAHARI were similar between patients assigned to MIEBO or hypotonic saline control in the GOBI study5
  • 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 45
  • Most patients (93.8%) were considered compliant with dosing5

Select outcome measures5

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: 0-100.5

Study limitations include open-label design, lack of a control group, and exclusion of patients with severe dry eye (tCFS >11).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. 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. Published online November 3, 2023. doi:10.1097/ICO.0000000000003418 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

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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.