Tenpoint Therapeutics, Ltd. (Tenpoint) has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for BRIMOCHOL PF, its treatment for presbyopia. BRIMOCHOL PF is a once-daily, preservative-free, fixed-dose combination of a cholinergic miotic (carbachol 2.75%) and an alpha-2 agonist (brimonidine tartrate 0.1%) in an eye drop. The combination modulates the pupil, creating a “pinhold effect,” the company said in a press release, intended to improve the depth of focus and sharpening near and distant images, with the benefit of greater peak efficacy and duration relative to monotherapy alone. This formulation would be the first combination therapy for presbyopia if approved by the FDA, the press release said.

The NDA submission includes efficacy and safety data, and is supported by positive data from the first phase 3 BRIO-I study, which demonstrated the benefit of the combination therapy over the individual components (required for FDA approval of a fixed-dose combination). In a second vehicle-controlled phase 3 BRIO-II study, the press release continued, BRIMOCHOL PF achieved all primary and secondary near-vision improvement endpoints with statistically significant 3 lines or greater improvement in binocular uncorrected near visual acuity over 8 hours, without the loss of one line or more in binocular uncorrected distance visual acuity. The eye drop was well-tolerated with no serious treatment-related adverse events observed in the over 70,000 treatment days monitored in the BRIO-II study, Tenpoint said.