MIEBO (perfluorohexyloctane ophthalmic solution) has been approved by the FDA for the treatment of dry eye disease (DED). The approval is based on data from two Phase 3 clinical trials, GOBI and MOJAVE, which demonstrated significant improvements in both corneal staining and dryness symptoms in patients treated with MIEBO compared to saline control.
The trials, involving a total of 1,217 patients, were randomized, saline-controlled, double-masked, and parallel-group studies. Patients received MIEBO four times daily over an 8-week period. The co-primary endpoints were the change from baseline in total corneal fluorescein staining (tCFS) and eye dryness score (EDS) at Day 57.
Efficacy Results
Both the GOBI and MOJAVE trials met their co-primary endpoints. Specifically, MIEBO-treated patients experienced a statistically significant improvement in corneal smoothness and a reduction in eye dryness symptoms compared to the saline group.
For corneal staining, the GOBI trial showed a treatment difference of -0.97 (95% CI: -1.40, -0.55) and the MOJAVE trial showed a treatment difference of -1.21 (95% CI: -1.66, -0.76) at Day 57.
In terms of eye dryness score, the GOBI trial showed a treatment difference of -7.61 (95% CI: -11.82, -3.40) and the MOJAVE trial showed a treatment difference of -10.24 (95% CI: -14.35, -6.08) at Day 57.
Safety Profile
The most common adverse events associated with MIEBO were blurred vision (3.0%) and conjunctival hyperemia (1.1%). Headache was reported in 1.1% of patients. The overall safety profile was considered favorable, with no significant differences observed across sex, race, and age subgroups.
Demographic Analysis
Across the two trials, the mean age of participants was approximately 60 years, with a range from 19 to 88 years. The majority of subjects were female (approximately 76%) and White (approximately 75%). Subgroup analyses indicated that the efficacy and safety of MIEBO were consistent across these demographic groups.
Clinical Significance
Dry eye disease is a chronic and progressive condition affecting millions of people worldwide. Symptoms include discomfort, visual disturbance, and tear film instability. MIEBO offers a new treatment option that directly addresses tear evaporation, a key factor in DED. The results from the GOBI and MOJAVE trials support the use of MIEBO as an effective and well-tolerated treatment for the signs and symptoms of dry eye disease.
