cCFS, central corneal fluorescein staining.
†GOBI and MOJAVE were 2 pivotal 57-day, multicenter, double-masked, saline-controlled studies conducted in adults ≥18 years old with a self-reported history of DED in both eyes and clinical signs of MGD. Patients administered 1 drop of MIEBO 4 times daily (QID) during the study. Primary endpoints were change from baseline (CFB) in total corneal fluorescein staining (tCFS) score and CFB in eye dryness score (Visual Analog Scale [VAS]) at Day 57. Day 15 was the earliest time point at which signs and symptoms were evaluated in the trials, and Day 57 was the last.1,3,4
‡KALAHARI was a 52-week, multicenter, single-arm, open-label extension study in adults ≥18 years who completed the GOBI study. The primary endpoint was the occurrence of ocular and non-ocular adverse events. Study limitations include open-label design, lack of a control group, and exclusion of patients with severe dry eye (tCFS score >11).8
§The phase 4 study 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 MGD (score 23 on a 0-15 scale) were included and received MIEBO QID for 14 days. 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.9
||At the 5-minute post-dose assessment on Day 1 of the phase 4 study, patients selected up to 3 terms (out of 10) to describe how MIEBO felt when placed in the eyes. The majority chose silky (68.7%), smooth (67.7%), and soothing (65.7%).9
¶Questionnaire was given on Day 1 of the GOBI and MOJAVE studies. Mean pooled comfort score was 8.0 for MIEBO and 8.4 for saline (scale of 0-10, 0 = not comfortable and 10 = very comfortable). 81% of patients treated with MIEBO reported a score of 7 or higher.10
#The exact mechanism of action for MIEBO in DED is not known.1
**PIVOTAL TRIALS INDIVIDUAL STUDY DATA1,3,4,10:
tCFS scores: GOBI: Mean baseline (standard deviation [SD]) 6.7 (1.8) for MIEBO vs 6.7 (1.9) for control; 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 baseline (SD) 7.0 (2.0) for MIEBO vs 7.1 (2.1) for control; 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.
cCFS scores: GOBI: Mean baseline (SD) 1.1 (0.8) for MIEBO vs 1.1 (0.8) for control; 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 baseline (SD): 1.1 (0.7) for MIEBO vs 1.2 (0.8) for control; 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.
