By Jordana Joy, Associate Editor
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.
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. The 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
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Source: Optometry Times