Visus Therapeutics Inc. presented topline clinical data from its pivotal phase 3 trial BRIO-1 for its lead investigational asset, Brimochol PF—a once-daily eye drop to correct the loss of near vision associated with presbyopia.
Refresh me on Brimochol PF.
Brimochol PF is a topical, preservative-free, and fixed-dose ophthalmic solution consisting of a combination of carbachol and brimonidine tartrate (both FDA-approved).
The formulation creates and sustains a “pinhole effect” by reducing the pupil size to allow only centrally-focused light rays to enter the eye, resulting in enhanced, sustainable vision and clarity for near (i.e. reading, smartphone/tablet use) and intermediate visual tasks (i.e. staring at a computer screen).
Now talk about this study.
The 3-arm, multicenter, double-masked, randomized, safety and efficacy study (NCT05270863) enrolled 182 patients (ages 45-80) diagnosed with emmetropic phakic and pseudophakic presbyopia.
Participants received either a combined single drop of Brimochol PF, a single drop of Carbachol PF, or a single drop of Brimonidine tartrate at each visit.
What was the primary endpoint?
The main endpoint, prespecified by the FDA, included achieving ≥15 ETDRS letter gain in binocular near visual acuity (BNVA) without a loss of ≥5 letters at distance across all time points through Hour 6 (carbachol p=0.006; brimonidine p=0.039).
And the findings?
Brimochol PF achieved the primary endpoint for BCVA across multiple time points (starting at hour 1) and was reportedly well tolerated with no significant adverse events (AEs).
How about secondary endpoints?
Brimochol PF was found to be statistically significant in both prespecified secondary endpoints: the proportion of patients achieving a 10-letter gain in letters at near distance and in the number of patients achieving at least 20/40 at near VA.
There was also a statistically significant gain observed in distance vision of 2 letters at 8 hours compared to active control, carbachol (p = 0.047) and versus baseline at all time points (p < 0.001).
Is that it?
Nope, there’s more … there was also a statistically significant reduction in pupil size for all time points up to 10 hours as well as improvement in distance vision at 8 hours.
Any side effects?
Not really; Brimochol PF was well-tolerated with less than 10% of patients reporting headaches (and no treatment-related serious adverse events).
Significance?
The fixed-dose combination product is the first of its kind to achieve the FDA’s requirement of statistically significant “contribution-of-elements” in presbyopia.
Basically, that means it’s reaching uncharted territory in the presbyopia drop space.
So what’s next?
Visus expects to report topline results from an ongoing pivotal phase 3, 6-month plus 6-month safety and efficacy interim study (BRIO-II) later in 2023.
If all goes well, the company plans to file a new drug application (NDA) in 2024.