YUVEZZI 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
The United Kingdom YUVEZZI submission is an important milestone for Tenpoint Therapeutics’ continued global expansion strategy
LONDON & WARREN, N.J.--(BUSINESS WIRE)--Tenpoint Therapeutics, Ltd., 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 Medicines and Healthcare products Regulatory Agency (MHRA) for the review and approval of YUVEZZI™ (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% – a once-daily, dual-agent (combination) eye drop – for the treatment of presbyopia in adults. The MAA was submitted via the MHRA’s International Recognition Procedure (IRP), which is a streamlined regulatory pathway, and will consider the U.S. Food and Drug Administration (FDA) approval as part of the Procedure.
“Submitting to the MHRA is a meaningful step in our commitment to bringing YUVEZZI to patients beyond the U.S. 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. “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.”
Tenpoint Therapeutics is also executing on its plans to submit regulatory applications for YUVEZZI in key regions around the world.
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
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, YUVEZZI significantly improved near vision with one drop, once a day.4 Additionally, YUVEZZI achieved miosis from 30 minutes up to 10 hours.4 YUVEZZI was well-tolerated with no treatment-related serious adverse events observed in the more than 72,000 dosing days monitored in BRIO II.4
About YUVEZZI™
YUVEZZI™ (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% is a once-daily, dual-agent eye drop approved by the U.S. Food & Drug Administration (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
YUVEZZI combines two medicines that work together to improve close-up vision. Carbachol helps pupils get smaller (or “constrict”), making it easier to focus up close. Brimonidine helps keep pupils from getting too large (or “dilating”).
For more information about YUVEZZI and full Prescribing Information, please visit www.YUVEZZI.com. Eye care professionals can visit www.YUVEZZIECP.com for additional resources.
YUVEZZI™ Important Safety Information
Do not use YUVEZZI if you are allergic to any of its ingredients or if you currently have inflammation of the iris (iritis).
Before taking YUVEZZI, tell your doctor if you have depression, low blood pressure, or circulation problems.
YUVEZZI may cause temporary blurry, dim, or dark vision. If you experience this, avoid driving, using machinery, and participating in hazardous activities. Use caution when night driving and in other activities in low light.
Call your doctor right away if you suddenly have flashes of light, floaters, or vision loss.
Do not let the tip of the vial touch your eye, eyelid, or any other surface.
The most common side effects of YUVEZZI are headache, impaired vision, and temporary eye pain and/or eye irritation upon use. These are not all of the possible side effects of YUVEZZI.
Most side effects were generally mild, didn’t last long, and went away on their own.
About Tenpoint Therapeutics
Tenpoint Therapeutics, Ltd. is a global commercial ophthalmic pharmaceutical company focused on the commercialization of YUVEZZITM (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, the first and only dual-agent eye drop for the treatment of presbyopia, a condition that affects nearly 128 million people in the U.S. and approximately 2 billion people globally.1,3 By understanding real-world needs and partnering with eye care professionals, Tenpoint is working to bring innovation to the aging eye.
This press release is intended for US audiences only
To learn more, visit tenpointtherapeutics.com and connect on LinkedIn.
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1 American Optometric Association Health Policy Institute. New Approaches to Presbyopia. 2023. Accessed November 5, 2025. Available at https://www.aoa.org/AOA/Documents/Advocacy/HPI/presbyopia%20brief%20HPI%20Final.pdf. |
2 National Eye Institute. Presbyopia. National Eye Institute. December 4, 2024. https://www.nei.nih.gov/learn-about-eye-health/eye conditions-and-diseases/presbyopia. Accessed January 7, 2026. |
3 Fricke TR, Tahhan N, Resnikoff S, et al. Global Prevalence of presbyopia and vision impairment from uncorrected presbyopia: systematic review, meta-analysis and modelling. Ophthalmology. 2018;125(10):1492–9. |
4 YUVEZZI US Prescribing Information. Visus Therapeutics, Inc.; 2026. |
Contacts
Media:
Brandi Robinson
media@tenpointtx.com
Eye Care Trade Media
Michele Gray
michele@mgraycommunications.com
Investors:
Ami Bavishi or Nick Colangelo
Gilmartin Group LLC
tenpoint@gilmartinir.com
