Tenpoint Therapeutics has submitted a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for YUVEZZI, an eye drop being developed to treat presbyopia in adults.

The application is being reviewed through the MHRA’s International Recognition Procedure, which allows previous regulatory decisions from recognised international regulators to support the assessment process. The submission follows approval of YUVEZZI by the US Food and Drug Administration (FDA) in January 2026.

Presbyopia is an age-related condition that causes gradual loss of near vision and usually begins after the age of 45. It can affect everyday activities including reading, using smartphones and viewing objects at close range.

The condition affects an estimated two billion people globally, with current management options including reading glasses, contact lenses and surgical procedures.

Tenpoint Therapeutics chief executive officer Henric Bjarke said: “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.”

The company said the submission is supported by data from two Phase 3 randomised, double-masked, controlled studies, BRIO I and BRIO II.

Across the studies, YUVEZZI was evaluated as a once-daily eye drop containing carbachol and brimonidine tartrate. The treatment works by reducing pupil size, which can improve the eye’s ability to focus on nearby objects.

Results from the trials showed improvements in near vision following treatment, with pupil constriction observed from 30 minutes up to 10 hours after dosing. In the BRIO II study, Tenpoint reported that no treatment-related serious adverse events were observed during more than 72,000 dosing days.

Tenpoint Therapeutics is also preparing regulatory submissions for YUVEZZI in additional regions as it continues international expansion.

If approved in the UK, YUVEZZI would become a prescription eye drop option for adults with presbyopia, providing an alternative to existing approaches for managing age-related near vision loss.