US Food and Drug Administration approves Miebo for dry eye disease
The drug is the first FDA-approved treatment for dry eye disease that directly targets tear evaporation
05 June 2023
Miebo, developed by Bausch + Lomb and Novaliq, has been approved by the US Food and Drug Administration (FDA) for the treatment of dry eye disease.
Reacting to the approval, Bausch + Lomb’s chairman and chief executive, Brent Saunders, said the company expected to be able to make the drug commercially available in the US within the second half of 2023.
“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,” he said.
The approval comes following two phase three clinical trials involving 1217 dry eye disease patients who were prescribed either Miebo or a placebo hypotonic saline solution.
After two months, patients given Miebo experienced reductions in eye dryness using a visual analogue scale and in total corneal fluorescein staining compared to the placebo group.
The most common adverse reactions were blurred vision and eye redness, which appeared in 1-3% of individuals.
Dosage of Miebo involves instilling one drop in each eye four times daily. The solution contains perfluorohexyloctane, which forms a monolayer at the air-liquid interface of the tear film and reduces evaporation.