Miebo Approved to Treat Signs and Symptoms of Dry Eye Disease

The Food and Drug Administration (FDA) has approved Miebo^™ (perfluorohexyloctane ophthalmic solution) for the treatment of the signs and symptoms of dry eye disease.

While its exact mechanism of action in the treatment of dry eye disease is unknown, Miebo, a semifluorinated alkane, forms a monolayer at the air-liquid interface of the tear film that can be expected to reduce evaporation.

The approval was based on data from the phase 3 GOBI (ClinicalTrials.gov Identifier: NCT04139798) and MOJAVE (ClinicalTrials.gov Identifier: NCT04567329) studies, which evaluated the efficacy and safety of Miebo in a total of 1217 adults 18 years of age and older with dry eye disease and clinical signs of meibomian gland dysfunction. Patients were randomly assigned 1:1 to receive either Miebo or hypotonic saline solution 4 times daily.

The coprimary endpoints for both studies were the change from baseline to day 57 in total corneal fluorescein staining (tCFS), as assessed by the National Eye Institute scale, and in Dryness Score, as assessed on a visual analogue scale (VAS).

Findings demonstrated a statistically significant improvement in tCFS at day 57 in the Miebo arm compared with the saline arm in both the GOBI (-2.0 [2.6] vs -1.0 [2.7], respectively; P <.001) and MOJAVE (-2.3 [2.8] vs -1.1 [2.9], respectively; P <.001) studies. 

Additionally, Miebo was associated with a statistically significant improvement in VAS eye dryness score on day 57 vs saline in both the GOBI (-27.4 [27.9] vs -19.7 [26.7], respectively; P <.001) and MOJAVE (-29.5 [28.6] vs -19.0 [27.2], respectively; P <.001) studies. Statistically significant improvements in tCFS and VAS eye dryness score were also observed at day 15 (secondary endpoint). The most common adverse event reported was blurred vision.

“Today’s FDA approval of Miebo further advances DED treatment by addressing a significant unmet need for millions of people suffering with this disease,” said Brent Saunders, chairman and CEO, Bausch + Lomb. “We are proud to bring to market the first and only prescription eye drop approved in the United States for the treatment of DED that directly targets evaporation. We expect to make Miebo commercially available in the second half of this year.”