Tenpoint’s Therapeutics has received U.S. Food and Drug Administration approval for Yuvezzi, an eye drop for presbyopia, an age-related condition that makes it difficult to focus on nearby objects. The approval makes Yuvezzi the first combination treatment cleared for presbyopia. The drug combines two active ingredients that have each been available on the market for decades.
Yuvezzi is a solution containing 2.75% carbachol and 0.1% brimonidine tartrate. Presbyopia affects an estimated 2 billion people worldwide, including approximately 128 million individuals in the United States. The condition develops as the eye’s lens becomes more rigid with age, limiting the ability to focus on close objects. Management has traditionally relied on over-the-counter reading glasses, prescription eyewear, or contact lenses.
Both components of Yuvezzi have long-standing use in ophthalmology. Carbachol was first marketed in 1972 as Alcon’s Miostat, where it was used to constrict pupils during cataract surgery. Brimonidine tartrate was commercialized in 1996 by Allergan as a treatment for ocular hypertension and was later sold by Bausch + Lomb as Lumify to reduce eye redness. Yuvezzi combines these agents to constrict the pupil and prevent dilation, creating a pinhole effect that improves visual acuity and depth of focus.
The FDA approval was supported by two Phase 3 clinical trials. One study showed that Yuvezzi was superior to each of its individual components, a requirement for fixed-dose combination products. The second, vehicle-controlled trial met all primary endpoints related to vision improvement and demonstrated sustained efficacy over eight hours. Participants received treatment for 12 months, the longest safety study conducted for a presbyopia therapy, and no serious adverse treatment effects were reported.
The most common side effects included headache, impaired vision, and temporary eye pain. In one study, about 3% of participants receiving Yuvezzi reported eye redness, compared with roughly 11% of those who received carbachol alone.
Yuvezzi was originally developed by Visus Therapeutics, a Seattle-based company founded seven years ago. Visus merged with Tenpoint Therapeutics about 13 months ago in a deal led by David Guyer, M.D., who serves as chairman of both companies. Discussing the rationale for the merger, Tenpoint Chief Executive Officer Henric Bjarke said, “And then you had Tenpoint, which had a very exciting but early-stage pipeline. And they had a broad base of investors.”
Bjarke took over as CEO in December 2024 and was hired for his experience launching ophthalmic drugs. He said Tenpoint has reached a headcount of 100 employees and has hired about two-thirds of its planned sales force. The full team is expected to include 76 sales representatives targeting 12,200 physicians across 8,800 offices. By the end of the year, the company expects to have between 180 and 200 employees.
Alongside the approval, Tenpoint raised $85 million in a Series B financing round led by Janus Henderson, EQT Nexus, Hillhouse, and the British Business Bank. The company also secured a $150 million debt facility from Hercules Capital, which will be drawn in installments. Tenpoint said the funding will support the launch of Yuvezzi, which is expected to begin early in the second quarter of this year.
Tenpoint’s FDA Approval Signals Major Eye-Care Innovation
Tenpoint’s has reached a significant milestone with FDA approval of Yuvezzi, positioning Tenpoint’s as a key innovator in prescription eye-drop therapies. Tenpoint’s Yuvezzi becomes the first combination eye drop approved for presbyopia, highlighting how Tenpoint’s is addressing unmet needs in age-related vision care. Through this approval, Tenpoint’s strengthens its presence in the competitive ophthalmology market.
Tenpoint’s Yuvezzi Offers Non-Surgical Presbyopia Solution
Tenpoint’s Yuvezzi provides patients with a non-surgical alternative to reading glasses and invasive procedures, reinforcing Tenpoint’s patient-centric strategy. By combining two active agents, Tenpoint’s Yuvezzi improves near vision while maintaining distance clarity, demonstrating Tenpoint’s commitment to balanced treatment outcomes. Tenpoint’s continues to focus on convenience and safety with once-daily dosing.
