May 25, 2023 — Bausch + Lomb has announced that the U.S. Food and Drug Administration (FDA) has approved Miebo for treating signs and symptoms of dry eye disease (DED).
 
Formerly known as NOV03, the water- and preservative-free perfluorohexyloctane ophthalmic solution is the first FDA-approved treatment for DED that directly targets tear evaporation, according to the company. Tear evaporation due to an altered tear lipid layer is a leading cause of DED, often associated with the clinical signs of meibomian gland dysfunction (MGD). An unstable tear film can result in increased ocular surface desiccation, inflammation, and damage to the ocular surface, and Bausch + Lomb shares that Miebo is designed to reduce tear evaporation at the ocular surface.
 
"In the two pivotal clinical trials, Miebo addressed the persistent and chronic nature of DED by providing sustained improvement in both the signs and symptoms of DED,” says Preeya Gupta, M.D., cornea and cataract surgeon at Triangle Eye Consultants. “Because Miebo inhibits evaporation, it may be an appropriate treatment option for patients whose tear evaporation exceeds tear supply.”
 
The FDA’s approval resulted from two 57-day, multicenter, randomized, double-masked, saline-controlled studies of a total of 1,217 patients with a history of DED and clinical signs of MGD. (An estimated 86% of people with DED have excessive tear evaporation because of MGD.) In both studies, Miebo met primary sign and symptom efficacy endpoints, the company shares, with patients experiencing relief of symptoms as early as day 15 and through day 57.
 
For more information: bausch.com.