AbbVie Inc.'s Allergan unit on Tuesday said a Phase 3 study of twice-daily use of its Vuity eye drops met the main endpoint in adults with age-related blurry near vision, also known as presbyopia.
Allergan said the study, which met the primary endpoint of improving near vision without compromising distance vision at hour nine on day 14, would form the basis of an application for expanded approval of Vuity that the company plans to file with the U.S. Food and Drug Administration in the second quarter.
The FDA last year approved once-daily use of Vuity as the first and only eye drop to treat age-related blurry near vision in adults.
Allergan, which AbbVie acquired in 2020 in a $63 billion deal, said roughly 128 million people in the U.S. experience presbyopia, which reduces the eye's ability to focus on near objects and usually affects people after age 40.
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