General Information

Miebo (perfluorohexyloctane ophthalmic solution) is a semifluorinated alkane designed to reduce tear evaporation at the ocular surface.

Miebo is specifically indicated for the treatment of the signs and symptoms of dry eye disease.

Miebo is supplied as a solution for topical administration. Instill one drop of Miebo four times daily into affected eye(s). Contact lenses should be removed prior to and for at least 30 minutes after the administration of Miebo.

Mechanism of Action

Miebo (perfluorohexyloctane), a semifluorinated alkane, contains 6 perfluorinated carbon atoms and 8 hydrogenated carbon atoms. Perfluorohexyloctane forms a monolayer at the air-liquid interface of the tear film which can be expected to reduce evaporation. The exact mechanism of action for Miebo in dry eye disease is not known.  

Side Effects

Adverse effects associated with the use of Miebo may include, but are not limited to, the following:

• blurred vision
• eye redness

Clinical Trial Results

The FDA approval of Miebo was based on results from two 57-day, multi-center, randomized, double-masked, saline-controlled studies, GOBI and MOJAVE, which enrolled a total of 1,217 patients with a history of dry eye disease (DED) and clinical signs of Meibomian gland dysfunction (MGD), a major cause of development and disease progression. An estimated 86% of people with DED have excessive tear evaporation whereby MGD is the major contributor.

In both pivotal studies, Miebo met both primary sign and symptom efficacy endpoints. The two primary endpoints were change from baseline at week eight (day 57 ± 2) in total corneal fluorescein staining (tCFS) and eye dryness Visual Analog Scale (VAS) score. Patients experienced relief of symptoms as early as day 15 and through day 57 with statistically significant reduction in VAS eye dryness score favoring Miebo observed in both studies. Additionally, at days 15 and day 57, a significant reduction in tCFS favoring Miebo was observed in both studies.