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

PRIMARY ENDPOINT

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

Total Corneal Fluorescein Staining (tCFS)2-4

magnifying-glass
Total corneal fluorescein staining chart
2x IMPROVEMENT vs control in total CFS at Day 571,4

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; CFS, corneal fluorescein staining.

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

magnifying-glass
Eye dryness chart
1.5x IMPROVEMENT vs control in eye dryness at Day 571,4

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.

SECONDARY ENDPOINT

Significant improvements in CENTRAL corneal fluorescein staining at Day 574

Central Corneal Fluorescein Staining (cCFS)4

magnifying-glass
Central corneal fluorescein staining chart
4x IMPROVEMENT vs control in central CFS at Day 574

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.

PRIMARY ENDPOINT

Rapid and sustained improvement in TOTAL corneal 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
2x IMPROVEMENT vs control in total CFS at Day 571,4

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; CFS, corneal fluorescein staining.

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
1.5x IMPROVEMENT vs control in eye dryness at Day 571,4

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 –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.

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
4x IMPROVEMENT vs control in central CFS at Day 574

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.

Study design

The first and only approved Rx eye drop that required all patients in pivotal studies to have clinical signs of MGD at enrollment

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

Efficacy and safety were established in 2 large clinical trials that enrolled >1200 patients2,3

GOBI and MOJAVE: Two 57-day, multicenter, double-masked, saline-controlled studies2,3

Key inclusion criteria:

  • Adults ≥18 years old with self-reported history of DED in both eyes2,3
  • MGD defined as a total MGD score ≥3
  • Based on secretion of 5 central glands on lower eyelid (each scored 0-3); 0 = normal; 1 = thick/yellow, whitish, particulate; 2 = paste; 3 = none/occluded

Baseline characteristics (depending on study and treatment arm)4*:

  • Mean total MGD score: 7.6
  • Mean tCFS: 6.9
  • Mean TFBUT (sec): 3.2
  • Mean OSDI score: 54.6
  • Eye dryness VAS score: 65.6
GOBI and MOJAVE study design summary GOBI and MOJAVE study design summary

*GOBI (MIEBO vs control [SD], respectively): Mean total MGD score, 7.4 (3.1) vs 7.7 (3.2); mean tCFS, 6.7 (1.8) vs 6.7 (1.9); mean TFBUT (sec), 3.2 (0.8) vs 3.3 (0.8); mean OSDI score, 53.9 (17.6) vs 54.4 (17); eye dryness VAS score, 66.5 (19.1) vs 66.8 (18.7). MOJAVE (MIEBO vs control [SD], respectively): Mean total MGD score, 7.9 (3.5) vs 8.1 (3.5); mean tCFS, 7.0 (2.0) vs 7.1 (2.1); mean TFBUT (sec), 3.2 (0.9) vs 3.1 (0.9); mean OSDI score, 55.2 (17.4) vs 55.8 (17.2); eye dryness VAS score, 64.7 (19.5) vs 64.3 (19.8).2,3

OSDI, Ocular Surface Disease Index; QID, 4 times a day; TFBUT, tear film break-up time.

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INDICATION

MIEBO™ (perfluorohexyloctane ophthalmic solution) is a semifluorinated alkane 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; 2023. 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; 2023.

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INDICATION AND IMPORTANT
SAFETY INFORMATION

INDICATION

MIEBO™ (perfluorohexyloctane ophthalmic solution) is a semifluorinated alkane 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.