Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), announced that its US partner Visus Therapeutics Inc., has published positive topline results from the pivotal Phase III BRIO-I trial.
BRIO-I Trial Success and Regulatory Milestones
The BRIO-I trial successfully met the pre-specified primary study endpoints that were agreed upon with both the US-FDA and EMA/MHRA. The trial demonstrated the benefits of the once-daily BRIMOCHOL PF, a fixed dose combination of carbachol and bimonidine, over carbachol and brimonidine monotherapies. BRIMOCHOL PF showed highly statistically significant improvements in near and distance binocular visual acuity at multiple time points, and clinically and statistically significant reductions in pupil size out to 10 hours. The treatment was well-tolerated, with no treatment-related serious adverse events reported.
BRIMOCHOL PF: A Daily Pupil Adjustment Eye Drop for Presbyopia
BRIMOCHOL PF is a once-a-day pupil adjustment eye drop without preservatives, designed for the treatment of loss of close-range vision due to presbyopia. In May 2022, Zhaoke entered into a licensing agreement with Visus, securing development and commercialization rights to BRIMOCHOL PF in Greater China, South Korea, and designated Southeast Asian regions.-Fineline Info & Tech
