Presbyopia Eye Drop From Startup Tenpoint Gets FDA Approval, Paving Way for $235M Financing Leave a comment
The gradual loss of near vision that is a natural part of aging can be addressed by glasses, contact lenses, or even surgical procedures. A presbyopia eye drop developed by Tenpoint Therapeutics now has FDA approval, joining a small group of similar products that offer patients an alternative to eyewear or surgery.
The FDA’s Wednesday regulatory decision covers the treatment of presbyopia in adults. Tenpoint expects its once-daily eye drop, brand name Yuvezzi, will launch in the second quarter of this year.
Yuvezzi was known in development as Brimochol, a combination of the drug’s two active ingredients, brimonidine and carbachol. Both are established eye drugs. Brimonidine reduces intraocular eye pressure to treat glaucoma; carbachol treats glaucoma and is also used to constrict pupils during cataract surgery. Together, Yuvezzi’s two ingredients are intended to constrict the pupil, creating a pinhole effect that improves near vision and depth of focus.
Tenpoint’s regulatory submission was based on two Phase 3 studies that enrolled a total of 536 patients with presbyopia. Results showed that showed the fixed-dose combination of the drug’s two active ingredients demonstrated superior benefit in visual acuity compared to each of the active ingredients administered separately. This benefit lasted eight to 10 hours each day. The most common adverse effects reported in the studies included headache, impaired vision, and temporary eye pain or eye irritation. Eye redness was not a commonly reported side effect.
There are other eye drops developed to create the pinhole effect to treat presbyopia. AbbVie was first with Vuity, approved 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 in presbyopia lasts only up to six hours and the product did not get much market traction. In 2022, AbbVie decided to reduce sales and marketing for Vuity.
In 2023, the FDA approved Orasis Pharmaceuticals’ formulation of pilocarpine, branded as Qlosi. This eye drop lasts up to eight hours and may be administered twice a day. Lenz Therapeutics brings a different approach with Vizz, a once-daily eye drop whose active ingredient, aceclidine, contracts the iris sphincter muscle to offer near-vision improvement lasting up to 10 hours. Vizz landed its FDA approval last July and launched in October. In preliminary fourth quarter 2025 financial results released earlier this month, Lenz reported $1.6 million in net product revenue from more than 20,000 prescriptions filled in the quarter.
William Blair analyst Lachlan Hanbury-Brown, who follows Lenz, said in a Thursday research note that Vizz has a stronger profile with data showing greater efficacy, faster onset of effect, and longer durability in a broader population. He also pointed out that the Yuvezzi label flags the risk of blood circulation problems as well as potential drug-drug interactions, risks that are not listed on Vizz’s label. Hanbury-Brown said it’s unclear how these differences will be viewed by clinicians and patients, but William Blair believes they highlight the Lenz product’s differentiation from the field.
“Overall, while we continue to believe Vizz has a best-in-class profile, we also believe that having a second voice in the market promoting therapies for presbyopia may help expand the market,” Hanbury-Brown said.
London-based Tenpoint emerged in 2023 as a preclinical startup focused on developing cell therapies for vision disorders. At that time, then CEO Eddy Anglade said the name referred to 10 microseconds, which is the time it takes for the brain to process an image that hits the retina.
In 2024, the company merged with Seattle-based startup Visus Therapeutics and kept the Tenpoint name. Visus had already completed the first Phase 3 test of Brimochol and was looking ahead to an FDA submission. The combined company also raised an undisclosed amount of financing to complete the second Phase 3 test of Brimochol and prepare for commercialization of the presbyopia eye drop. Cell therapy is still part of Tenpoint’s pipeline, but that research remains preclinical.
Following Yuvezzi’s approval, Tenpoint announced on Wednesday $235 million in new financing, which breaks down to a $150 million credit facility with Hercules Capital and an $85 million Series B round. The Series B financing was led by Janus Henderson, EQT Nexus, Hillhouse, and British Business Bank. Earlier investors that also participated in the round include EQT Life Sciences, Sofinnova Partners, F-Prime, Eight Roads, Qiming Venture Partners USA, AdBio, and Wille. Tenpoint said the capital will support commercialization of Yuvezzi.
“We deeply appreciate the support of our strong syndicate of global, long-term investors,” Tenpoint CEO Henric Bjarke said in a prepared statement. “This financing reflects their confidence in Yuvezzi, a new differentiated option for millions of people living with the daily frustration and challenges of presbyopia.”
Photo by Flickr user Lily MAP via a Creative Commons license
