
GOBI pivotal study
DOWNLOADEfficacy 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
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
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
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.
SIGN IMPROVEMENT
Total Corneal Fluorescein Staining
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
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.
SYMPTOM RELIEF
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
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.
SIGN IMPROVEMENT
Central Corneal Fluorescein Staining
SECONDARY ENDPOINT
Significant improvements in CENTRAL corneal fluorescein staining at Day 574
Central Corneal Fluorescein Staining (cCFS)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.
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
Key inclusion criteria:
Baseline characteristics (depending on study and treatment arm)4*:
*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.
MIEBO™ (perfluorohexyloctane ophthalmic solution) is a semifluorinated alkane indicated for the treatment of the signs and symptoms of dry eye disease.
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.
MIEBO™ (perfluorohexyloctane ophthalmic solution) is a semifluorinated alkane indicated for the treatment of the signs and symptoms of dry eye disease.
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.