The product, branded YUVEZZI\u2122, received approval from the U.S. Food and Drug Administration (FDA) in January 2026 as the first and only dual-agent (combination) eye drop approved for the treatment of presbyopia in adults <\/p>\n
The United Kingdom submission is an important milestone for Tenpoint Therapeutics’ continued global expansion strategy <\/p>\n
LONDON & WARREN, N.J., July 13, 2026<\/strong>–(BUSINESS WIRE<\/a>)–Tenpoint Therapeutics, Ltd.<\/a>, a global commercial ophthalmic pharmaceutical company focused on developing groundbreaking treatments to improve vision in the aging eye, today announced the submission of a Marketing Authorization Application (MAA) to the United Kingdom’s MHRA for the review and approval of YUVEZZI\u2122 (carbachol and brimonidine tartrate ophthalmic solution) 2.75%\/0.1% \u2013 a once-daily, dual-agent (combination) eye drop \u2013 that has been developed for the treatment of presbyopia in adults. The MAA was submitted via the MHRA’s International Recognition Procedure, which is a streamlined regulatory pathway, and will consider the U.S. FDA approval as part of the Procedure. <\/p>\n Tenpoint Therapeutics is also executing on its plans to submit regulatory applications for the product in key regions around the world. <\/p>\n Presbyopia is the gradual loss of close-up vision that typically begins around age 45 and affects approximately 2 billion people globally.1,2,3 Presbyopia can make simple things harder, like reading, texting, or checking labels at the store.1 <\/p>\n The MAA submission is supported by positive data from two Phase 3, randomized, double-masked, controlled studies, BRIO I and BRIO II. In the studies, the product significantly improved near vision with one drop, once a day.4,5 Additionally, the product achieved miosis from 30 minutes up to 10 hours.4 The product was well-tolerated with no treatment-related serious adverse events observed through up to 12 months and >72,000 dosing days.4,5 <\/p>\n About The Product<\/strong> <\/p>\n YUVEZZI\u2122 (carbachol and brimonidine tartrate ophthalmic solution) 2.75%\/0.1% is a once-daily, dual-agent eye drop approved by the U.S. FDA for the treatment of presbyopia, a condition characterized by the gradual loss of close-up vision that typically begins around age 45.3,4,5 <\/p>\n