Carbachol/Brimonidine Tartrate

Tenpoint Therapeutics' newly approved Yuvezzi can improve the up-close vision of patients with presbyopia, potentially allowing them to discard their reading glasses. Combining two eye drops that have been on the market for at least 30 years each has earned Tenpoint Therapeutics an FDA approval (PDF) for Yuvezzi, a treatment for presbyopia, a common, age-related condition that makes it difficult to focus on nearby objects.Yuvezzi, which is a solution of 2.75% carbachol and 0.1% brimonidine tartrate, becomes the first combination treatment for presbyopia, which affects roughly 2 billion around the world and 128 million in the United States.Carbachol reached the market in 1972 as Alcon’s Miostat to dilate pupils during cataract surgeries. Brimonidine tartrate was commercialized in 1996 by Allergan as an ocular hypertension eye drop and most recently by Bausch+Lomb as Lumify, a treatment to reduce eye redness.Along with the approval, London-based Tenpoint raised (PDF) a Series B round of $85 million led by Janus Henderson, EQT Nexus, Hillhouse and the British Business Bank. Additionally, Tenpoint has secured a $150 million debt facility from Hercules Capital, which the company will pull down in installments.The funding will facilitate Yuvezzi’s launch, which Tenpoint expects to kick off early in the second quarter of this year.Yuvezzi—also known as Brimochol PF—was originally developed by Visus Therapeutics, a seven-year-old Seattle company, which merged 13 months ago with Tenpoint. Forging the partnership was the chairman of both biotechs, David Guyer, M.D.“(Visus) had a pretty narrow group of key investors, but they had a really exciting pipeline,” Tenpoint CEO Henric Bjarke said in an interview with Fierce. “And then you had Tenpoint, which had a very exciting but early-stage pipeline. And they had a broad base of investors.”Bjarke, who took over in December of 2024, was brought in for his experience launching ophthalmic drugs. He said Tenpoint recently reached a headcount of 100 and has hired two-thirds of its sales force, which will eventually include 76 sales reps targeting 12,200 physicians across 8,800 offices. By the end of this year, Bjarke expects to have 180 to 200 employees on board.The approval was backed by two phase 3 trials. The first study demonstrated Yuvezzi’s superiority over its individual components, which is a requirement the FDA imposes on fixed-dose combo treatments. The vehicle-controlled second study achieved all vision improvement endpoints and sustained efficacy measures over eight hours. With participants receiving treatments for 12 months, which is the longest safety study ever conducted for presbyopia, there were no serious adverse treatment effects.The dual action provided by Yuvezzi includes carbachol to constrict the eye’s pupil and brimonidine to stop it from dilating. Keeping the pupil small creates a pinhole effect, improving visual acuity and depth of focus.“Carbachol is the drug that creates the miotic effect, or the reduction of the size of your pupil,” Bjarke explained. “And brimonidine increases the amount of carbachol that reaches the target tissue, so you get better effect and longer duration.” The approval of Yuvezzi comes just six months after the FDA signed off on another presbyopia treatment, Lenz Therapeutics’ eye drop Vizz. Analysts at William Blair have pegged Vizz, which has a unique mechanism of action, as a potential blockbuster.Other presbyopia drugs have had difficulty gaining a foothold in the market. Much was expected of AbbVie’s Vuity, which was approved in 2021, but the product hasn’t generated enough revenue to appear in the company’s quarterly financial reports. Orasis Pharmaceuticals scored a 2023 FDA approval for presbyopia drug Qlosi but the company didn’t launch the eye drop until April of 2025.“We have a competitive product. We have an innovative product and we have a strong story to tell around it,” Bjarke said when asked about other competition.Bjarke calls the market “enormous” and believes there is room for multiple products.“If you are an individual who’s had glasses all your life, this might not be something for you,” Bjarke said. “But people who live an active life—either through work or through hobbies—where they go to their activity and it forces them to put on and take off their glass, it’s very frustrating.” In his practice in Laguna Hills, California, John Hovanesian, M.D., of Harvard Eye Associates, sees many patients who are looking for another alternative.“The impact of presbyopia is often underestimated and current solutions like glasses, contacts or surgery have fallen short in meeting the real-world needs of people who struggle with close-up tasks,” Hovanesian said in the release.