The FDA accepted a new drug application for Brimochol PF for the treatment of presbyopia and set a Prescription Drug User Fee Act date of Jan. 28, 2026, according to a press release from Tenpoint Therapeutics.
Brimochol PF combines carbachol and brimonidine tartrate to create a pinhole effect, reducing pupil size and sharpening near and distant images. It was studied for the treatment of presbyopia in the phase 3 BRIO-I and BRIO-II pivotal trials.
“If approved, Brimochol PF will be the first and only fixed-dose combination product for the treatment (Read more...)