Nicole DeFeudis
Editor
Bausch + Lomb and Novaliq secured an approval for their dry eye disease drop on Thursday, to be marketed as Miebo.
The drug, also known as perfluorohexyloctane ophthalmic solution or previously NOV03, targets tear evaporation, a leading cause of dry eye disease. Bausch + Lomb CEO Brent Saunders expects the drug to be available in the second half of this year.
“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,” Andrew Stewart, president of ophthalmic pharmaceuticals, said in a news release.
Bausch+ Lomb declined to reveal Miebo’s price, adding that it would do so “at the time of commercial availability.”
Miebo’s approval was based on two Phase III studies in which the drug met its primary sign and symptom endpoints, change from baseline at week eight in total corneal fluorescein staining (tCFS) and score on the eye dryness Visual Analog Scale (VAS). The studies enrolled more than 1,200 patients in total, and the most common adverse reactions in the treatment arm were blurred vision and eye redness, according to the companies.
Millions of Americans experience dry eye disease, which can damage the ocular tissues and cornea and lead to blurry vision and even, in severe cases, vision loss. A handful of competitors are vying for a space in the multibillion-dollar market, including Aldeyra, which is expecting an FDA decision in November on its reproxalap to treat the signs and symptoms of dry eye disease.
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