LONDON and WARREN, N.J.,—Tenpoint Therapeutics, Ltd., a global commercial-stage ophthalmic pharmaceutical company focused on developing treatments to improve vision in the aging eye, has submitted 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, according to an announcement from the company.
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, the company said in the announcement.
“Submitting to the MHRA is a meaningful step in our commitment to bringing Yuvezzi to patients beyond the U.S.,” said Henric Bjarke, chief executive officer of Tenpoint Therapeutics. “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. 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.”
The MAA submission is supported by positive data from two phase 3, randomized, double-masked, controlled studies, BRIO I and BRIO II, which showed Yuvezzi significantly improved near vision with one drop, once a day, the company noted, adding that it is also planning to submit regulatory applications for Yuvezzi in other key regions around the world.
Marked by the gradual loss of close-up vision that typically begins around age 45, presbyopia affects approximately two billion people globally.
