Phase III pivotal BRIO-I trial of brimochol PF in Presbyopia
Visus Therapeutics reported positive topline results from its Phase III pivotal BRIO-I trial for the treatment of Presbyopia. BRIO-I met the pre-specified primary study endpoints agreed upon with the US-FDA and EMA/MHRA, demonstrating contribution of elements for the once-daily, fixed-dose combination, brimochol PF, over both active comparators carbachol and brimonidine monotherapies. Brimochol PF demonstrated highly statistically significant improvements in near and distance binocular visual acuity at multiple timepoints over carbachol and brimonidine
Clinically and statistically significant reductions in pupil size were also observed out to 10 hours. Brimochol PF was well-tolerated with no treatment-related serious adverse events.
BRIO-I is a 3-arm, multicenter, randomized, double-masked, crossover safety and efficacy study of Brimochol PF (carbachol/brimonidine tartrate fixed-dose combination) topical ophthalmic solution vs. carbachol monotherapy topical ophthalmic solution vs. brimonidine tartrate monotherapy topical ophthalmic solution in subjects with emmetropic phakic or pseudophakic presbyopia. Further details will be presented at upcoming meetings, including Eyecelerator during the 2023 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins