FDA Approves Yuvezzi (carbachol and brimonidine tartrate) Ophthalmic Solution to Treat Presbyopia

Tenpoint Therapeutics, Ltd., a global, commercial biotechnology company focused on developing groundbreaking treatments to improve vision in the aging eye, today announced that the U.S. Food and Drug Administration (FDA) approved Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, previously known as Brimochol™ PF, the first and only dual-agent eye drop for the treatment of presbyopia in adults. Presbyopia, the gradual loss of near vision that typically begins around age 45, affects about two billion people globally and 128 million people in the U.S.3,4,5 Yuvezzi is expected to be broadly commercially available in the U.S. in Q2 2026.

Carbachol

brimonidine 

Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% isthe only dual-agent presbyopia-correcting eye drop intentionally designed to deliver durability, tolerability, and safety

Yuvezzi was studied in two pivotal Phase 3 trials enrolling more than 800 patients, including the world’s largest and longest safety study for presbyopia eye drops1,2

Yuvezzi achieves miosis from 30-minutes up to 10 hours with one drop daily1

The FDA approval of Yuvezzi is based on positive data from two Phase 3 studies. The Phase 3 BRIO I study demonstrated a superior benefit of the combination therapy over the individual actives – a requirement for FDA approval of a fixed-dose combination.1 In the second Phase 3 study, BRIO II, which was vehicle-controlled, Yuvezzi achieved all primary near vision improvement endpoints with statistically significant three-lines or greater improvement in binocular uncorrected near visual acuity (BUNVA) over 8 hours, without the loss of one line or more in binocular uncorrected distance visual acuity (BUDVA).2 In addition, Yuvezzi was well-tolerated with no treatment-related serious adverse events observed in the more than 72,000 treatment days monitored in BRIO II, the longest safety study (12 months) conducted in presbyopia to-date.2 The most common side effects of Yuvezzi are headache, impaired vision and temporary eye pain or eye irritation.6

Eye redness was not a commonly reported side effect in clinical trials of Yuvezzi. In BRIO I and BRIO II the reports of adverse events of ocular hyperemia (eye redness) were low.1,2 In BRIO II, the rate of reported adverse events of ocular hyperemia (eye redness) was lower in subjects receiving Yuvezzi (2.8%) than carbochol alone (10.7%).2

“The FDA approval of Yuvezzi represents a significant milestone for the millions of people in the U.S. living with presbyopia and its daily frustrations and challenges,” said Henric Bjarke, Chief Executive Officer of Tenpoint Therapeutics. “As the first FDA-approved dual-agent eye drop for presbyopia, Yuvezzi leverages the mechanisms of carbachol and brimonidine tartrate to deliver sharp near vision with favorable tolerability. People deserve treatments that not only work but also can fit conveniently into their daily lives, and Yuvezzi brings an innovative new option to the presbyopia category. This approval marks the first groundbreaking therapy for Tenpoint Therapeutics aimed at advancing our mission to bring innovation to the aging eye.”

“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,” said John Hovanesian, M.D., FACS, of Harvard Eye Associates in Laguna Hills, California. “Yuvezzi introduces a novel approach by combining carbachol and brimonidine tartrate in a single daily eye drop that sharpens near vision and maintains tolerability throughout the day. Yuvezzi was intentionally designed to deliver both efficacy and tolerability, which represents an important step forward in delivering a complete, noninvasive option for people with presbyopia.”

“Presbyopia remains a universal and progressive condition that requires individualized management strategies,” said Mile Brujic, OD, FAAO, of Premier Vision Group in Bowling Green, Ohio. “I’m excited that I will be able to offer my patients YuvezziTM, the first-of-its-kind eye drop well-suited for long-term use. For people seeking a reliable, lifestyle-friendly solution to manage their near vision challenges in aging eyes, Yuvezzi is a valuable and practical advancement.”

“We’ve been working diligently to bring Yuvezzi to the eye care community and to the millions of adults looking for the optimal solution to address their frustration with presbyopia,” said Carol Kearney, Chief Commercial Officer of Tenpoint Therapeutics. “It was important to us that we provide an option that fits seamlessly into active, social and professional lifestyles, and we intentionally designed Yuvezzi to offer the right balance of efficacy, tolerability and ease of use.”

https://en.wikipedia.org/wiki/Carbachol

https://go.drugbank.com/drugs/DB00484

FDA Approves Yuvezzi (carbachol and brimonidine tartrate) Ophthalmic Solution to Treat Presbyopia

How statins harm muscles—and how to stop it

In continuation of my update  on statin 

Statins have transformed heart health, saving millions of lives by lowering cholesterol and reducing the risk of heart attacks and strokes. But for many patients, these drugs come with a troubling downside: muscle pain, weakness and, in rare cases, severe muscle breakdown that can lead to kidney failure.

University of British Columbia researchers and their collaborators at the University of Wisconsin-Madison have now pinpointed the cause. Their findings, published last week in Nature Communications, could pave the way for a new generation of statins without these side effects.

How statins affect muscle cells

The team used cryo-electron microscopy, a powerful imaging technique that reveals proteins at near-atomic detail, to capture how statins interact with a critical muscle protein called the ryanodine receptor (RyR1). This protein acts like a gatekeeper for calcium inside muscle cells, opening only when muscles need to contract. When statins bind to it, they force the gate open, causing calcium to leak continuously—a toxic effect that can damage muscle tissue.

"We were able to see, almost atom by atom, how statins latch onto this channel," said lead author Dr. Steven Molinarolo, a postdoctoral researcher in UBC's department of biochemistry and molecular biology. "That leak of calcium explains why some patients experience muscle pain or, in extreme cases, life-threatening complications."

Implications for future statin development

The study focused on atorvastatin, one of the most widely prescribed statins, but the findings suggest the effect may be common across the drug class. The researchers discovered that statins bind in a highly unusual way: Three molecules cluster together inside a pocket of the protein. The first molecule attaches when the channel is closed, priming it to open. Two more molecules then wedge in, forcing the channel wide open.

"This is the first time we've had a clear picture of how statins activate this channel," said Dr. Filip Van Petegem, senior author and professor at UBC's Life Sciences Institute. "It's a big step forward because it gives us a roadmap for designing statins that don't interact with muscle tissue."

By adjusting only those parts of the statin molecule that are responsible for the negative effects, scientists could preserve the part that lowers cholesterol while reducing the risk.

https://en.wikipedia.org/wiki/Statin

How statins harm muscles—and how to stop it