The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane ophthalmic solution) to treat the signs and symptoms of dry eye disease (DED).
Formerly known as NOV03, Miebo is a first-in-class eye drop designed for preventing the evaporation of excessive tears and restoring tear balance in evaporative DED patients.
It is the first and only prescription eye drop to receive FDA approval to treat DED that targets tear evaporation directly.
Bausch + Lomb chairman and CEO Brent Saunders stated: “Today’s FDA approval of Miebo further advances DED treatment by addressing a significant unmet need for millions of people suffering with this disease.
“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 regulatory approval is based on the findings obtained from pivotal Phase III GOBI and MOJAVE trials.
The two 57-day, double-masked, multi-centre, saline-controlled, randomised trials were conducted in 1,217 people with DED history and clinical signs of Meibomian gland dysfunction, a major cause of development and disease progression.
The findings showed that Miebo met its primary clinical sign and patient-reported symptom endpoint.
Blurred vision and eye redness are the most common adverse reactions observed with Miebo.