FDA Approves Bausch + Lomb and Novaliq's Miebo for the Treatment of the Signs and Symptoms of Dry Eye Disease

Bausch + Lomb announced on Thursday that the FDA has approved Miebo (perfluorohexyloctane ophthalmic solution; formerly known as NOV03) for the treatment of the signs and symptoms of dry eye disease (DED). The comapnies say Miebo is the first and only FDA-approved treatment for DED that directly targets tear evaporation.

Miebo, which is administered as a single drop into each eye and is given four times a day, is designed to reduce tear evaporation at the ocular surface.

“Today’s FDA approval of Miebo further advances DED treatment by addressing a significant unmet need for millions of people suffering with this disease,” Brent Saunders, chairman and CEO of Bausch + Lomb, said in a company news release. “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.”

The approval marks the first prescription eye treatment to be approved by the FDA since Bausch + Lomb became an independent, publicly traded eye health company last May. 

The FDA approval of Miebo was based on results from two 57-day, multicenter, randomized, double-masked, saline-controlled studies, GOBI and MOJAVE, which enrolled a total of 1,217 patients with a history of DED and clinical signs of 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 the GOBI and MOJAVE, 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.

The most common adverse reactions experienced with Miebo were blurred vision (1.3-3%) and eye redness (1-3%).

“Tear evaporation, which is a leading driver of DED, presents a significant treatment challenge. With the approval of Miebo, eye care professionals can now take a new approach to DED therapy with a first-in-class water- and preservative-free prescription treatment option that specifically addresses tear evaporation,” said Paul Karpecki, OD, director, Cornea and External Disease at Kentucky Eye Institute, and associate professor, University of Pikeville, at the Kentucky College of Optometry.

In 2019, Bausch Health entered into an agreement with Germany-based Novaliq in which Bausch acquired an exclusive license for the commercialization and development of the the investigational treatment NOV03, which is now branded at Miebo, in the United States and Canada. Financial terms of the deal were not disclosed. Under the terms of the licensing agreement, Novaliq is eligible to receive upfront and milestone payments based on regulatory and commercialization milestones, and sales royalties based on annual net sales of NOV03 in the United States and Canada.