Tenpoint Therapeutics Announces United Kingdom 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
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 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 – 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.
Tenpoint Therapeutics is also executing on its plans to submit regulatory applications for the product 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, 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
About The Product
YUVEZZI™ (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
For more information about the FDA’s approval of YUVEZZI, including its full Prescribing Information, please visit www.YUVEZZI.com.
About Tenpoint Therapeutics
Tenpoint Therapeutics, Ltd. is a global commercial ophthalmic pharmaceutical company focused on the commercialization of a product (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, as a dual-agent eye drop for the treatment of presbyopia, a condition that affects nearly 128 million people in the U.S., up to 30 million in the UK, and approximately 2 billion people globally.1,3,6 By understanding real-world needs and partnering with eye care professionals, Tenpoint is working to bring innovation to the aging eye.
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. |
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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. |
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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. |
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4 |
Visus Therapeutics, Inc. Data on file. VT-002 Clinical Study Report. 2023. |
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5 |
Visus Therapeutics, Inc. Data on file. VT-003 Clinical Study Report. 2025. |
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6 |
Association of British Dispensing Opticians. Modern Management of Presbyopia. Part 3: Surgical Methods. Published September 2022. Accessed July 8, 2026. Available at: https://www.abdo.org.uk/wp-content/uploads/2022/08/CPD-C-102987-with-REFS.pdf. |
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Contact
Media:
Brandi Robinson
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Eye Care Trade Media
Michele Gray
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Investors:
Ami Bavishi or Nick Colangelo
Gilmartin Group LLC
[email protected]
Abstract
Tenpoint Therapeutics announced the submission of an MAA to the United Kingdom’s MHRA for the review of YUVEZZI™ for the treatment of presbyopia.
