FDA gives green light for AbbVie’s VUITY to treat presbyopia

The approval made VUITY the first and only eye drop approved for this common condition

On Friday, AbbVie announced the FDA approval of VUITY™ for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. VUITY is the first and only FDA-approved eye drop to treat this prevalent and degenerative eye disease, affecting about 128 million Americans, nearly half of the U.S. adult population. “Most adults cope with presbyopia, or difficulty with near vision, as we age. Beginning around the age of 40, many find themselves using reading glasses, holding text further away, or even increasing the font size and lighting on screens to try to see more clearly,” said AbbVie Vice Chairman and President Dr. Michael Severino, M.D., in the press release. The FDA approval was based on data from two phase 3 trials that assessed the drug's efficacy, safety, and tolerability.

VUITY met the primary endpoint in both investigations. Compared with the vehicle drug, significantly greater proportion of patients treated with VUITY could read three more lines on a reading chart without having their distance vision impacted three hours after treatment at day 30. Additionally, improvement by VUITY appears to be fast-acting, starting as early as 15 minutes after treatment, according to AbbVie. "I am particularly encouraged by the rapid onset of action and duration of efficacy for VUITY to improve near and intermediate vision without impacting distance vision with one drop daily, particularly for those with mild to moderate presbyopia." George O. Waring IV, M.D., principal study investigator of the two trials. However, VUITY may not be the only presbyopia eye drop for long as an Eyenovia product is close behind.