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News|Articles|November 1, 2021
FDA Approves AbbVie’s Vuity for Presbyopia Treatment
Author(s)Pharmaceutical Technology Editors
Abbvie’s Vuity (pilocarpine HCI ophthalmic solution) is the first and only eye drop to receive FDA approval for the treatment of presbyopia.
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Allergan, a subsidiary of AbbVie, announced on Oct 29, 2021, that FDA approved Vuity (pilocarpine hydrochloric acid ophthalmic solution) 1.25% for the treatment of presbyopia, also known as age-related blurry near vision, in adults. According to a company press release, Vuity is the first and only FDA-approved eye drop to treat this condition, which affects an estimated 128 million Americans.
FDA approval came after two Phase III clinical studies, GEMINI and GEMINI 2, designed to evaluate the safety, tolerability, and efficacy of Vuity in the treatment of presbyopia. Both studies met the primary endpoint of improving near vision in low light conditions without a loss of distance vision on day 30 at hour three. Improvement was seen as early as 15 minutes and lasted 6 hours.
"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 Michael Severino, vice-chairman and president, AbbVie, in the press release. "We are proud to offer [Vuity] as a first-of-its-kind once-daily eye drop that we believe will change the way people and their eye doctors approach presbyopia. The FDA approval of [Vuity] exemplifies our continued pursuit of innovative new treatments that push the boundaries of what's possible in eye care."
"As we age, the lenses of our eyes become less flexible, making it more difficult to focus on things up close. [Vuity] offers a novel, safe, well-tolerated and effective alternative to current options for managing age-related blurry near vision," said George O. Waring IV, medical director of the Waring Vision Institute South Carolina, and GEMINI 1 and GEMINI 2 principal study investigator, in the press release. "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."
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