FDA Approves VUITY™ for the Treatment of Presbyopia

Allergan announced the U.S. Food and Drug Administration (FDA) approval of VUITY (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. VUITY eye drops are the first and only FDA-approved eye drop to treat this common and progressive eye condition that affects 128 million Americans, nearly half of the U.S. adult population.

As we age, presbyopia (impaired near vision) becomes a common problem for adults. When reaching the age of 40 or so, many people start using reading glasses, holding material farther away, or even raising the font size and illumination on screens in an attempt to improve their vision 

After 15 minutes and lasting up to six hours, VUITY eye drops are daily, prescription drops that improve near and intermediate vision without affecting distance vision. An established eye-care treatment, pilocarpine, is improved in VUITY for presbyopia and given with pHast™ technology. pHast™ technology enables VUITY to swiftly adjust its pH to the tear film’s physiologic PH. VUITY uses the eye’s natural ability to shrink pupil size to improve near vision without impacting far vision.

“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, M.D., FACS, medical director, Waring Vision Institute, South Carolina, and GEMINI 1 and GEMINI 2 principal study investigator. “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.”  

Based on findings from two key phase 3 clinical studies, GEMINI 1 and GEMINI 2, the FDA has approved VUITY eye drops for the treatment of presbyopia based on its efficacy, safety, and tolerability. On day 30 of both experiments, VUITY satisfied the primary goal, which was statistically significant improvement of close vision in low light (mesopic) circumstances without a loss of distance vision. Even after just 15 minutes, a noticeable difference could be detected and lasted for six hours. The GEMINI 1 and GEMINI 2 studies found no significant side effects in subjects who received VUITY. Headaches and eye redness were the most common side effects that occurred more than 5% of the time.