Tenpoint Therapeutics has submitted a Marketing Authorization Application to the United Kingdom Medicines and Healthcare products Regulatory Agency for YUVEZZI, a once-daily dual-agent eye drop (carbachol and brimonidine tartrate 2.75%/0.1%) developed to treat presbyopia in adults.
The MAA was filed through the MHRA’s International Recognition Procedure and will take into account the product’s U.S. Food and Drug Administration approval granted in January 2026.
The submission is supported by data from two Phase 3 randomized, double-masked controlled studies, BRIO I and BRIO II, which the company says showed significant improvement in near vision with one drop once daily and reported miosis lasting from 30 minutes up to 10 hours.
According to the company, YUVEZZI was well tolerated with no treatment-related serious adverse events observed through up to 12 months and more than 72,000 dosing days.
Tenpoint is pursuing regulatory applications in additional regions as part of its global commercial strategy, and the company cites prevalence estimates that presbyopia affects roughly 2 billion people worldwide.
