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Tenpoint Therapeutics Submits MAA for YUVEZZI to MHRA for Presbyopia Treatment in Adults

on July 14, 2026

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Tenpoint Therapeutics 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% for the treatment of presbyopia in adults.

YUVEZZI received U.S. FDA approval in January 2026 as the first and only dual‑agent (combination) eye drop for presbyopia.

The MAA was submitted via MHRA’s International Recognition Procedure (IRP), which uses the U.S. FDA approval as part of the assessment.

The MAA submission is supported by positive data from two Phase 3, randomized, double‑masked, controlled studies, BRIO I and BRIO II.

Sources:

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

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BREAKING: The FDA approval of Yuvezzi (carbachol and brimonidine ...

Tenpoint wins FDA nod for combination presbyopia eye drop

Adult brimonidine BRIO I BRIO II carbachol Eye Drops Healthcare products International Recognition Procedure Marketing Authorization MHRA Phase 3 trials presbyopia regulatory agency Tenpoint Therapeutics YUVEZZI

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