Tenpoint submitted an NDA for Brimochol preservative-free (PF) for the treatment of presbyopia, an age-related condition of near-vision loss. The combination product contains brimonidine, an alpha-2 agonist, and carbacol, a cholinergic agent, and is designed to produce a “pinhole effect” to sharpen near and distant vision. Brimochol PF is a preservative-free, once-daily eyedrop. In the Phase 3, double-masked BRIO-1 study, Brimochol PF achieved the primary endpoint of proportion of participants achieving more than a 15 letter gain in near visual acuity without a loss of five letters or more of distance acuity compared to carbachol (p=0.006) or brimonidine (p=0.039) alone that was seen across all time points through hour six.³ The study also demonstrated Brimochol PF achieved a statistically significant reduction in pupil size with Brimochol PF at all time points out to ten hours, and statistically significant improvement in distance vision at 8 hours, compared to the active controls. In addition, the Phase 3, BRIO-2 study reported similar improvement with the combination compared to carbachol alone. It also demonstrated statistically significant improvements in near vision versus vehicle at all timepoints out to 8 hours (p<0.008). ⁴ If approved, Brimochol PF would be the first combination therapy for presbyopia. It may have an advantage over the existing pilocarpine ophthalmic products Vuity and Qlosi, because it shows a duration of response out to eight hours with a single dose. Pilocarpine agents may require a second dose to achieve similar benefit.