Tenpoint Therapeutics 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 carbachol and brimonidine tartrate ophthalmic solution 2.75%/0.1% (Yuvezzi), 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, a streamlined regulatory pathway that will consider the drop’s FDA approval in January 2026 as part of the review process.
“Submitting to the MHRA is a meaningful step in our commitment to bringing Yuvezzi to patients beyond the [United States]. Blurry close-up vision is among the most prevalent age-related conditions in the [United Kingdom], 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 a press release.
Tenpoint Therapeutics is also working to submit regulatory applications for Yuvezzi in key regions around the world.