Recently, the FDA (U.S. Food and Drug Administration) approved the first eye drops for the treatment of presbyopia, Vuity (pilocarpine 1.25% eye drops), which was developed by Allergan in the United States and was officially approved on October 29, 2021 NDA.

Presbyopia is a common eye disease of presbyopia. The cause is decreased eye accommodation. The global incidence is extremely high. It mostly occurs in people over 45. The older the person, the higher the prevalence. According to incomplete statistics, the global At present, 1.8 billion people suffer from presbyopia, and the number of presbyopia in China exceeds 390 million. The main ingredient of Vuity eye drops is pilocarpine, which is an M-choline receptor agonist. The indication is for the treatment of presbyopia. The drug takes effect once a day for 15 minutes and lasts for up to 6 hours. The mechanism of action of the drug is to constrict the pupil through the dynamic pupillary adjustment effect to increase the depth of focus, improve near and intermediate vision, and maintain pupil responsiveness to different light intensities.

The FDA approval of the drug is based on data from two phase III clinical studies of 750 enrolled adult patients between 40 and 55 years old. These patients were randomly given Vuity or placebo at a ratio of 1:1, during which time each eye was given once a day. , Continuous administration for 30 days.

The clinical results showed that Vuity reached the primary endpoint: Compared with placebo, the proportion of patients in the drug group who got 3 or more lines (the ability to read 3 lines on the chart) was significantly higher than that in the placebo group. Significant improvement, and distance vision is not affected. It works in 15 minutes and lasts at least three hours, up to six hours. In terms of safety, in this study, no serious adverse events during the treatment period were observed in any patients treated with Vuity, and the most common non-serious adverse event (>5%) was headache. Most side effects are mild and short-lived, with only 1.2% of patients discontinuing the drug due to adverse events.

Reference source: [1]*USPI Template (rxabbvie.com)[2]FDA approvesAbbvie's Vuity eye drops for age-related farsightednessVuity(pilocarpine hydrochloride ophthalmic solution) (fda.gov)