FDA approves Vuity eye drop for presbyopia
The U.S. Food and Drug Administration has approved Vuity (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia in adults, according to a press release. This is the only FDA-approved eye drop for the treatment of presbyopia.
The prescription eye drop can work in as little as 15 minutes and can last up to 6 hours and improves near and intermediate vision without impacting distance vision.
Approval was based on data from the GEMINI 1 and GEMINI 2 phase 3 clinical studies. Vuity significantly improved near vision in low light conditions without losing distance vision on day 30 at hour 3 compared with placebo.
No serious adverse events were observed. Headache and eye redness were the most common adverse events reported.
“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, 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.”
Read the full press release here.