VAUGHAN, Ontario & HEIDELBERG, Germany—Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company, and Novaliq GmbH, a biopharmaceutical company focusing on ocular therapeutics, announced that the U.S. Food and Drug Administration (FDA) has approved Miebo (perfluorohexyloctane ophthalmic solution; formerly known as NOV03), for the treatment of the signs and symptoms of dry eye disease (DED). Miebo is the first and only FDA-approved treatment for DED that directly targets tear evaporation, according to the companies.

“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 U.S. for the treatment of DED that directly targets evaporation. We expect to make MIEBO commercially available in the second half of this year.”

In GOBI and MOJAVE, two phase 3 pivotal clinical trials which enrolled more than 1,200 patients (randomized 1:1 to Meibo or hypotonic saline) with a history of DED and clinical signs of Meibomian gland dysfunction (MGD), Miebo consistently met its primary clinical sign and patient-reported symptom endpoint.

"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,” said Preeya Gupta, MD, cornea and cataract surgeon, Triangle Eye Consultants, Raleigh, N.C. “Because Miebo inhibits evaporation, it may be an appropriate treatment option for patients whose tear evaporation exceeds tear supply.”

“Tear evaporation, which is a leading driver of DED, presents a significant treatment challenge. With the approval of Miebo, eyecare 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, Kentucky Eye Institute, and associate professor, University of Pikeville, Kentucky College of Optometry.

“Today’s FDA decision marks a tremendous milestone for Bausch + Lomb as Miebo becomes our first prescription pharmaceutical eye treatment to be approved by the FDA since becoming an independent, publicly traded eye health company,” said Andrew Stewart, president, ophthalmic pharmaceuticals, Bausch + Lomb. “We are proud to further deliver on our promise to bring innovative new options to help patients improve their treatment journey.”