Tenpoint Therapeutics submits UK MAA for Yuvezzi

Tenpoint Therapeutics, Ltd, has submitted a Marketing Authorization Application (MAA) to the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, a once-daily, dual-agent eye drop, for the treatment of presbyopia in adults, according to the company.²

The MAA was submitted through the MHRA's International Recognition Procedure, a streamlined regulatory pathway that considers the drug's US FDA approval as part of its review. Yuvezzi received FDA approval in January 2026 as what the company describes as the first and only dual-agent combination eye drop approved for presbyopia in adults, according to a news release.¹

"Submitting to the MHRA is a meaningful step in our commitment to bringing Yuvezzi to patients beyond the US. Blurry close-up vision is among the most prevalent age-related conditions in the UK, affecting a significant proportion of adults over the age of 45, yet currently there are no prescription eye drops approved to help people with their presbyopia," said Henric Bjarke, chief executive officer of Tenpoint Therapeutics, in the release. "If approved, Yuvezzi could help to build a new category of treatment and offer patients in the UK an alternative option for managing the everyday frustrations associated with blurry close-up vision."

The company said the UK submission is a milestone in its global expansion strategy and that it plans to submit regulatory applications for Yuvezzi in other key regions.²

Presbyopia, the gradual loss of close-up vision that typically begins around age 45, affects an estimated 2 billion people globally, according to the company. The condition can make tasks such as reading, texting or reading labels more difficult.²

The MAA submission is supported by data from 2 Phase 3, randomized, double-masked, controlled trials, BRIO I and BRIO II. In the studies, Yuvezzi significantly improved near vision with one drop administered once daily and achieved miosis from 30 minutes up to 10 hours. The company said Yuvezzi was well tolerated, with no treatment-related serious adverse events observed across more than 72,000 dosing days monitored in BRIO II.¹

According to Tenpoint, Yuvezzi combines 2 medicines: carbachol, which constricts the pupil to improve near-focus ability, and brimonidine, which the company says helps prevent the pupil from dilating.¹

Reference:

1. Tenpoint Therapeutics announces United Kingdom Yuvezzi submission of Marketing Authorization Application to the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of blurry close-up vision (presbyopia) in adults. News release. Businesswire. July 13, 2026. Accessed July 13, 2026. https://www.businesswire.com/news/home/20260713403162/en/Tenpoint-Therapeutics-Announces-United-Kingdom-YUVEZZI-Submission-of-Marketing-Authorization-Application-to-the-Medicines-and-Healthcare-Products-Regulatory-Agency-MHRA-for-the-Treatment-of-Blurry-Close-Up-Vision-Presbyopia-in-Adults

2. Presbyopia. National Eye Institute. December 4, 2024. Accessed July 13, 2026. https://www.nei.nih.gov/learn-about-eye-health/eye conditions-and-diseases/presbyopia.