Patients with dry eye disease (DED) reported symptom relief in as early as five and 60 minutes after a single administration of Bausch + Lomb’s new ophthalmic solution Miebo, with relief maintained through the 14-day study.  

Miebo is the first FDA-approved therapeutic directly targeting the excessive tear evaporation often associated with meibomian gland dysfunction (MGD). Its only component is perfluorohexyloctane (F6H8), a semifluorinated alkane that stabilises the tear film on the surface of the eye, reducing tear evaporation and drying of the eyes.   

Published by Ophthalmology and Therapy, the phase 4 findings build on results from the GOBI and MOJAVE pivotal studies in which patients experienced significant improvement in the signs and symptoms of DED as early as day 15, with continued improvement through day 57. 

The data builds 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, said Andrew Stewart, president, global pharmaceuticals and international consumer, Bausch + Lomb. “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.” 

The prospective, multicentre, open-label phase 4 study evaluated the effect of Miebo on symptom severity and frequency early in treatment. Inclusion criteria aligned with the phase 3 studies where all patients had a history of DED and evidence of MGD.  

Patients completed early outcome surveys during four clinic visits – day one pretreatment and at five and 60 minutes post first administration plus days three, seven and 14. Patients rated symptom severity, symptom frequency and treatment satisfaction on a visual analogue scale from 0 to 100. 

In Australia and New Zealand, perfluorohexyloctane (F6H8) is marketed by AFT Pharmaceuticals as Novatears.