FDA Approves Pilocarpine HCl Ophthalmic Solution for Patients With Presbyopia

Officials with the FDA have approved pilocarpine HCl ophthalmic solution 1.25% (Vuity, AbbVie) for the treatment of presbyopia, also known as age-related blurry near vision, in adults. According to a press release from AbbVie, Vuity is the first and only FDA-approved eye drop to treat this condition, which affects nearly half of the US adult population.

Vuity is a daily prescription eye drop that works to improve near and intermediate vision without impacting distance vision. Vuity is a formulation of pilocarpine, an established eye care therapeutic, delivered using AbbVie’s pHast technology, which allows Vuity to adjust to the physiologic pH of the tear film.

“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, MD, FACS, medical director of the Waring Vision Institute, in a 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.”

The FDA approval is based on the results of 2 phase 3 clinical studies, GEMINI 1 and GEMINI 2, which evaluated the efficacy, safety, and tolerability of Vuity for the treatment of presbyopia. In both studies, Vuity demonstrated a statistically significant improvement in near vision in low light (mesopic) conditions without a loss of distance vision versus placebo on day 30 at hour 3.

Further, these improvements were seen as early as 15 minutes and lasted through 6 hours. No serious adverse events (AEs) were recorded, with the most common AEs being headache and eye redness.

“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, MD, vice chairman and president of AbbVie, in the 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.”

REFERENCE

U.S. Food and Drug Administration approves Vuity™ (pilocarpine HCI ophthalmic solution) 1.25%, the first and only eye drop to treat presbyopia (age-related blurry near vision) [news release]. AbbVie; October 29, 2021. Accessed November 1, 2021. https://news.abbvie.com/news/press-releases/us-food-and-drug-administration-approves-vuity-pilocarpine-hci-ophthalmic-solution-125-first-and-only-eye-drop-to-treat-presbyopia-age-related-blurry-near-vision.htm