For patients with presbyopia, or age-related blurry near vision, wearing glasses or contact lens has long been the mainstay correction method. Thanks to a new FDA approval, they now have an eye drop option.
Friday, the FDA green-lit AbbVie’s Vuity for presbyopia, making the once-daily pilocarpine solution the first eye drop for the common eye condition.
The go-ahead opens up a large market, where 128 million Americans, mainly above the age of 40, suffer from long-sightedness, the Illinois pharma said. But still, a rival pilocarpine-based product from Eyenovia is closely behind.
Pilocarpine is already used to treat high pressure inside the eye caused by glaucoma or other eye diseases. For Vuity, AbbVie uses a proprietary technology dubbed pHast, which allows the drug to rapidly adjust to the pH of the tear film.
Vuity proved its case in presbyopia with two phase 3 studies. Compared with vehicle drug, significantly greater proportion of patients treated with Vuity could read three more lines on a reading chart without having their distance vision impacted three hours after treatment at day 30. The numbers were 31% and 8% for Vuity and dummy eye drop, respectively, in the Gemini 1 trial. The showing in Gemini 2 were 26% versus 11% between Vuity and vehicle. The two trials also recorded a difference between the two treatment arms to the six-hour mark.
What’s more, improvement by Vuity appears to be fast-acting, starting as early as 15 minutes after treatment, according to AbbVie.
“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,” Goerge Waring, M.D., from the Waring Vision Institute in South Carolina and principal investigator of the two phase 3 trials, said in a statement.
Vuity may not be the only presbyopia eye drop for long. In May, Eyenovia unveiled that its drug-device combo MicroLine also topped placebo at helping presbyopia patients gain three lines or more on a reading chart. The New York biotech is now planning to start a second phase 3 trial by year-end 2021.
The Eyenovia product uses the company’s Optejet dispenser to deliver small doses of pilocarpine. The device allows more consistent doses at about a fifth the drug volume of a traditional eye drop, according to the company.