Preservative-free ophthalmic treatment for presbyopia passes phase III trial
Alun Evans | | 2 min read | News
A new presbyopia-correcting drop, Brimochol PF, has passed the first phase III trials required by the FDA. Manufactured by Visus Therapeutics, Brimochol PF is a preservative-free, fixed-dose combination of carbachol 2.75 percent and brimonidine tartrate 0.1 percent; it is designed to be used once-daily.
The crossover study design enrolled 182 emmetropic patients aged 45–80; visual acuity and pupil size was measured repeatedly throughout the trial. Investigators found a statistically significant reduction in pupil size when using Brimochol PF, compared with the active controls (carbachol and brimonidine) at each time point. During the trial, Brimochol PF met primary FDA endpoints for presbyopia-correcting drops, as well as prespecified EU and Uk endpoints. There were no treatment-related serious adverse events. A second phase III study, comparing the drug to a vehicle control, is currently underway.