FDA approves AbbVie’s Vuity for the treatment of presbyopia


Abbvie’s Vuity (pilocarpine HCI ophthalmic solution) is the first and only eye drops to receive FDA approval for the treatment of presbyopia.

Allergen, a subsidiary of AbbVie, announced on October 29, 2021 that the FDA has approved Vuity (pilocarpine hydrochloric acid ophthalmic solution) 1.25% for the treatment of presbyopia, also known as vision near fuzzy age-related, in adults. Vuity is the first and only eye drops approved by the FDA to treat this disease, which affects approximately 128 million Americans, according to a press release from the company.

FDA approval came after two Phase III clinical studies, GEMINI and GEMINI 2, designed to assess the safety, tolerability and efficacy of Vuity in the treatment of presbyopia. Both studies met the primary endpoint of improvement in near vision in low light conditions without loss of distance vision on day 30 at the third hour. Improvement was seen as early as 15 minutes and lasted 6 hours.

“Most adults face presbyopia, or difficulty with near vision, as we get older. By the age of around 40, many find themselves using reading glasses, holding text away, or even increase the font size and lighting on the screens to try and see more clearly, “said Michael Severino, vice president and president of AbbVie, in the press release.” We are proud of to offer [Vuity] as a one-of-a-kind once-a-day eye drops that we believe will change the way people and their ophthalmologists approach presbyopia. FDA approval of [Vuity] illustrates our continued quest for innovative new treatments that push the boundaries of what is possible in eye care. “

“As we age, the lenses in our eyes become less flexible, making it harder to focus on things up close. [Vuity] offers a new, safe, well-tolerated and effective alternative to current options for managing age-related fuzzy near vision, ”said George O. Waring IV, medical director of the Waring Vision Institute in South Carolina and the ‘main study GEMINI 1 and GEMINI 2 researcher, in the press release. “I am particularly encouraged by the speed of action and the duration of effectiveness of [Vuity] to improve near and intermediate vision without impacting far vision with one drop per day, especially for people with mild to moderate presbyopia. “

Source: AbbVie

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