Bausch + Lomb publishes study results on early patient-reported outcomes with Miebo in patients with DED
Patients reported that Miebo significantly reduced overall symptoms severity at the primary endpoint of change from baseline in the severity of overall dry eye symptoms at day 7.
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Bausch + Lomb has published results from a Phase 4 study in Ophthalmology and Therapy that assessed early patient-reported outcomes with Miebo in patients with dry eye disease (DED).1 The results from the study titled “Early effects of perfluorohexyloctane ophthalmic solution on patient-reported outcomes in dry eye disease: a prospective, open-label, multicenter study” shed light on the benefits of the treatment after first use and during the first 2 weeks of treatment, according to a news release.
The data from the prospective, multicenter, open-label Phase 4 study builds on results previously compiled from GOBI and MOJAVE pivotal studies, in which significant improvements were documented in the signs and symptoms of DED as early as day 15 and with continued improvement through day 57.1
“We know that the symptoms of dry eye disease, which include eye dryness, blurred vision, burning, stinging and eye pain, can have a significant impact on daily activities such as reading, driving, working on a computer and using devices,” said Andrew Stewart, president of Global Pharmaceuticals and International Consumer at Bausch + Lomb, in the release. “These study results build on an impressive data set showing Miebo as a well-tolerated and effective treatment option for dry eye disease that also can deliver much-needed, fast-acting symptom relief. In particular, the study answers the question of how quickly patients can experience relief prior to day 15, which was the first evaluation point in the phase 3 studies.”
Specifically, the Phase 4 study evaluated to effect of Miebo on symptom severity and frequency early in treatment. Inclusion criteria was aligned with the Phase 3 studies assessing Miebo where all patients had a history of DED and evidence of meibomian gland dysfunction. Patient completed early outcome surveys during 4 clinical visits – day 1 pretreatment at 5 and 60 minutes post-first administration, day 3, day 7, and day 14. They rated symptom severity, symptom frequency, and treatment satisfaction on a visual analog scale (VAS) from 0 to 100 in part of the surveys.1
“Rapid relief of dry eye symptoms is an important factor for adherence to treatment,” said Shane R. Kannarr, OD, study author and optometrist at Kannarr Eye Care in Kansas. “These patient-reported results show that Miebo provided relief from dry eye symptoms quickly – in some cases in as little as 5 minutes after the patient’s first use – and that relief was maintained and improved over the 2-week period. The study also demonstrated high patient treatment satisfaction, another important element for patient compliance, and patients described the product as silky, smooth and soothing.”
Ultimately, patients reported that Miebo significantly reduced overall symptoms severity at the primary endpoint of change from baseline in the severity of overall dry eye symptoms at day 7. Mean overall symptom severity decreased significantly from 72.1 (17.0) at baseline to 27.8 (22.3) at day 7 (mean change, − 44.5). Additionally, significant symptom relief was observed within 5 and 60 minutes after a single administration on day 1. The mean score on the VAS for overall dry eye symptoms was 72.1 (17.0) at baseline and decreased to 38.5 (22.8) at 5 min post-administration and 31.7 (22.1) at 60 min post-administration.1
Mean frequency of awareness of dry eye symptoms and percentage of time experiencing the most bothersome symptoms also significantly declined between baseline and day 14, from 77.6% to 27.6% and 77.9% to 34.7%, respectively. Fluctuations in quality of vision also decreased significantly, from 62.8% at baseline to 19.4% on day 14. Median satisfaction ratings also increased from 83.0 on day 3, 86.0 on day 7, and 90.0 on day 14. Miebo was also well tolerated with no reports of treatment-related adverse events.1
Reference:
Bausch + Lomb announces publication of Phase 4 data on the early effects of Miebo (perfluorohexyloctane ophthalmic solution) on patient-reported outcomes in dry eye disease in Ophthalmology and Therapy journal. News release. Bausch + Lomb. March 20, 2025. Accessed March 20, 2025.
