Topical Pilocarpine for Presbyopia
By Jean Shaw
Selected and reviewed by Neil M. Bressler, MD, and Deputy Editors
Journal Highlights
JAMA Ophthalmology, April 2022
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Waring et al. evaluated the efficacy and safety of AGN-190584 (pilocarpine hydrochloride 1.25%) eyedrops, now sold as Vuity, in patients with presbyopia. They found that the drug was safe and effective.
For this randomized phase 3 study, known as Gemini 1, 323 participants with presbyopia were enrolled from Dec. 21, 2018, to Oct. 31, 2019, at 36 sites in the United States. All were 40 to 55 years old (mean, 49.6 years). The majority (n = 235, 72.8%) were female and White (n = 292, 90.4%). Their baseline mean distance-corrected near visual acuity (DCNVA) in mesopic (e.g., dim) lighting conditions was 29.2 letters. Effects of pilocarpine on night vision were not evaluated.
Participants were randomized to receive either Vuity (n = 163) or vehicle (n = 160) eyedrops, which were administered bilaterally once a day for 30 days. The main outcome measure was the proportion of participants with an improvement of 3 or more lines on day 30 at hours 3 and 6.
At hour 3 on day 30, 50 (30.7%) of those who received Vuity had improved by 3 or more lines in mesopic, high-contrast DCNVA, versus 13 (8.1%) of those who received vehicle. At hour 6 on day 30, those percentages were 18.4% and 8.8%, respectively. Overall, treatment with Vuity was well tolerated. (Also see related commentary by Kevin K. Ma, MD, and Jennifer Rose-Nussbaumer, MD, in the same issue.)
The original article can be found here.