Startup Tenpoint wins FDA approval for presbyopia eye drops, paving the way for $235 million in funding
The gradual loss of near vision is a natural part of aging and can be addressed with glasses, contact lenses, or even surgery. Presbyopia eye drops developed by Tenpoint Therapeutics have now received FDA approval, joining a small group of similar products that offer patients an alternative to glasses or surgery.
Wednesday's FDA regulatory decision covers treatments for presbyopia in adults. Tenpoint expects its once-daily eye drops, branded as Yuvezzi, to launch in the second quarter of this year.
Yuvezzi, known as Brimochol during development, is a combination of the drug's two active ingredients, brimonidine and carbachol. Both are proven eye remedies. Brimonidine reduces intraocular pressure to treat glaucoma; carbachol treats glaucoma and is also used to constrict the pupil during cataract surgery. Together, Yuvezzi's two ingredients work to constrict the pupil, creating a pinhole effect that improves near vision and depth of focus.
Tenpoint's regulatory submission is based on two Phase 3 studies that enrolled a total of 536 presbyopic patients. The results showed that a fixed-dose combination of the drug's two active ingredients showed superior benefits in terms of vision compared with taking each active ingredient alone. This benefit lasts for eight to ten hours a day. The most common adverse reactions reported in studies included headache, impaired vision, and temporary eye pain or eye irritation. Red eyes are not a common side effect.
There are other eye drops that create a pinhole effect to treat presbyopia. AbbVie first partnered with Vuity to gain approval in 2021. This once-daily drop is an optimized formulation of pilocarpine, a drug used to treat glaucoma and ocular hypertension. But Vuity's effect on presbyopia only lasted up to six hours, and the product didn't gain much market traction. In 2022, AbbVie decided to reduce sales and marketing of Vuity.
In 2023, the FDA approved Orasis Pharmaceuticals' pilocarpine formulation, branded Qlosi. The eye drops last up to eight hours and can be applied twice a day. Lenz Therapeutics is taking a different approach with Vizz, a once-daily eye drop whose active ingredient acelidine contracts the iris sphincter to improve near vision, with effects lasting up to 10 hours. Vizz received FDA approval last July and launched in October. In preliminary fourth-quarter 2025 financial results released earlier this month, Lenz reported more than 20,000 prescriptions filled during the quarter and net product revenue of $1.6 million.
Lachlan Hanbury-Brown, an analyst at William Blair who follows Lenz, said in a research note Thursday that Vizz is better known and has data showing higher efficacy, faster onset of action and longer persistence in a broader population. He also noted that the Yuvezzi label flags the risk of blood circulation problems and potential drug-drug interactions, while those risks are not listed on the Vizz label. Hanbury-Brown said it's unclear how clinicians and patients will view these differences, but William Blair believes they underscore how Lenz's products are different from the field.
“Overall, while we continue to believe Vizz has a best-in-class image, we also believe having a second voice in the market promoting presbyopia treatments may help expand the market,” Hanbury-Brown said.
Founded in 2023, London-based Tenpoint is a preclinical startup focused on developing cell therapies for vision impairment. At the time, then-CEO Eddy Anglade said the name referred to the 10 microseconds it takes for the brain to process an image that reaches the retina.
In 2024, the company merged with Seattle-based startup Visus Therapeutics and retained the Tenpoint name. Visus has completed its first Phase 3 testing of Brimochol and is awaiting FDA submission. The combined company also raised an undisclosed amount of financing to complete a second Phase 3 test of Brimochol and prepare for commercialization of presbyopia eye drops. Cell therapies remain part of Tenpoint's pipeline, but the research is still in the preclinical stage.
Following Yuvezzi's approval, Tenpoint on Wednesday announced $235 million in new financing, including a $150 million credit line from Hercules Capital and an $85 million Series B round. The Series B round was led by Janus Henderson, EQT Nexus, Hillhouse and British Business Bank. Early investors participating in this round include EQT Life Sciences, Sofinnova Partners, F-Prime, Eight Roads, Qiming Venture Partners USA, AdBio and Wille. Tenpoint said the funding will support the commercialization of Yuvezzi.
“We are extremely grateful for the support of a strong syndicate of long-term global investors,” Tenpoint CEO Henric Bjarke said in a prepared statement. “This financing reflects their confidence in Yuvezzi as a new, differentiated option for the millions of people who face the pain and challenges of presbyopia every day.”
Photo by Flickr user Lily, via Creative Commons license
