In March 2025, Bausch + Lomb reported publication of a prospective, multicenter, open-label Phase 4 study in Ophthalmology and Therapy evaluating the early effects of Miebo (perfluorohexyloctane ophthalmic solution) in patients with dry eye disease. The study enrolled 99 subjects with documented meibomian gland dysfunction and chronic DED, assessing patient-reported symptom relief within minutes post–first instillation and through two weeks of treatment. At 5 minutes post-dose, symptom severity scores dropped sharply (mean VAS from ~72.1 to ~38.5), further improving by 60 minutes (~31.7) and continuing through day 14 (~27.8). Symptom frequency declined from ~77.6% to ~27.6%, time experiencing bothersome symptoms fell from ~77.9% to ~34.7%, and fluctuations in visual quality improved significantly (~62.8% to ~19.4%). Patient satisfaction rose from median 83 at day 3 to 90 at day 14, with all measures indicating early onset and sustained symptom improvement. Importantly, no treatment-related adverse events were reported. These results complement prior pivotal trials (GOBI and MOJAVE), which evaluated outcomes over several weeks, by demonstrating that Miebo offers rapid relief within minutes of administration. The study reinforces Miebo’s unique tear-film stability mechanism—targeting tear evaporation—and underscores its differentiating role among DED therapies for patients seeking immediate symptomatic benefit.

Citation:
https://www.ophthalmologytimes.com/view/bausch-lomb-publishes-results-from-phase-4-study-evaluating-patient-reported-outcomes-with-miebo-in-dry-eye-disease

Implications:
These Phase 4 results position Miebo as a fast-acting, well-tolerated treatment for dry eye, offering noticeable symptom relief within minutes—an important consideration for patient preference and real-world engagement. The data reinforce its utility for meibomian gland dysfunction-associated DED and may shift prescribing trends toward earlier intervention with Miebo in treatment pathways.