Visus Therapeutics reported that the BRIO-I Phase 3 clinical trial met its primary and secondary endpoints, evaluating the safety and efficacy of BRIMOCHOL PF, a preservative-free ophthalmic solution for the treatment of presbyopia, a normal part of aging that makes it difficult to see things up close.
BRIMOCHOL PF successfully achieved the prespecified FDA primary endpoint based on the proportion of subjects achieving more than 15 ETDRS (early treatment diabetic retinopathy study) letter gain in binocular near visual acuity without a loss of five or more letters at distance across all time points through hour six.
“We believe the success of the study represents a strong opportunity to meet the market need for a true once-daily product with a very favorable tolerability profile,” Ben Bergo, co-founder and CEO of closely-held Visus, said in a statement.
BRIMOCHOL PF is also the first fixed-dose combination product to achieve prespecified EU and UK primary endpoints from 0.5 to eight hours duration and out to 10 hours.
Rhett Schiffman, M.D., co-founder, CMO and head of R&D with Visus, said the contribution of brimonidine on the overall performance of BRIMOCHOL PF is most clearly shown in the objective pupillometry results that show clinically and statistically significant reductions in pupil size over the individual therapies at all time points from 30 minutes out to 10 hours.
In addition, he said there is a gentle wearing-off of this miotic effect over 10 hours that is still sufficient to provide clinically meaningful improvements in visual performance over a full workday, while minimizing the likelihood of nighttime vision difficulties that can occur if miosis lasts too long.
Topline results from BRIO-II, an ongoing pivotal Phase 3, six-month plus six-month safety and efficacy interim study are expected in the second half of 2023. Following the read-out of BRIO-II, the company expects to file an NDA with the FDA in the second half of 2024.