China's First 30-Minute Onset Presbyopia Eye Drop YUVEZZI Approved for Use at Boao Super Hospital

On July 7, Zhaoke Ophthalmology announced that its innovative presbyopia drug, carbachol and brimonidine tartrate eye drops (YUVEZZI, 2.75%/0.1%), has been approved by the Hainan Provincial Drug Administration.Used as an urgently needed imported drug for clinical use at Boao Super Hospital.

This is FDA-approvedThe First Combination Eye Drops for the Treatment of PresbyopiaYUVEZZI: One drop daily,Onset of action within 30 minutes, lasting up to 10 hours。

YUVEZZI consists of fixed-dose carbachol (a cholinergic agonist) and brimonidine tartrate (an α2-adrenergic receptor agonist) at concentrations of 2.75% and 0.1%, respectively. These two components induce miosis, creating a “pinhole effect” that allows only centrally focused light to enter the eye, thereby sharpening images at near and intermediate distances. Compared with monotherapy, the core advantages of this combination formulation are higher peak efficacy and a longer duration of action.

This FDA approval is primarily based on positive data from two pivotal Phase III clinical trials (BRIO-I and BRIO-II). The BRIO-I study demonstrated that YUVEZZI’s efficacy was significantly superior to that of its individual components, thereby meeting one of the FDA’s core requirements for the approval of fixed-dose combination products.

In the second Phase III study, BRIO II (placebo-controlled), YUVEZZI met all primary endpoints for near vision improvement, achieving a statistically significant improvement of 3 lines or more in binocular uncorrected near visual acuity (BUNVA) within 8 hours, without a loss of 1 line or more in binocular uncorrected distance visual acuity (BUDVA).

Furthermore, YUVEZZI was well tolerated, with no treatment-related serious adverse events observed across more than 72,000 treatment days monitored in the BRIO II study. The press release noted that BRIO II is the longest safety study (12 months) conducted to date in the field of presbyopia. The most common side effects of YUVEZZI were headache, blurred vision, and transient eye pain or ocular irritation.

In the clinical trials of YUVEZZI, ocular hyperemia was not a common adverse reaction. In the BRIO I and BRIO II studies, the reporting rates of adverse events such as ocular hyperemia (eye redness) were low. In the BRIO II study, the reporting rate of ocular hyperemia (eye redness) among subjects treated with YUVEZZI (2.8%) was lower than that among subjects using carbachol alone (10.7%).

In May 2022, Zhaoke Ophthalmology entered into an exclusive licensing agreement with Tenpoint Therapeutics (formerly Visus), securing the rights to develop and commercially manufacture YUVEZZI in Greater China, South Korea, and designated Southeast Asian countries; in February 2024, the two parties further expanded their collaboration by extending the licensed territories to additional markets.In China,Zhaoke Ophthalmology is conductingYUVEZZI Phase II Clinical Trial for the Treatment of Presbyopia。

On December 8, 2025, Zhaoke Ophthalmology announced a strategic partnership with Taiwan’s Tung Sheng Hua Pharmaceutical to jointly advance the clinical development and future commercialization plans for YUVEZZI in the Taiwan region. Prior to collaborating with Tung Sheng Hua Pharmaceutical, Zhaoke Ophthalmology had already established commercial partnerships with local distributors in South Korea, Australia, New Zealand, Thailand, Indonesia, and the Middle East.

On November 6, 2025, Zhaoke’s South Korean partner, Kwangdong Pharmaceutical, submitted a New Drug Application for YUVEZZI in South Korea, marking the product’s first regulatory submission outside the United States.

Current treatment options for presbyopia are very limited. The frequent removal and replacement of eyeglasses cause considerable inconvenience in work and daily life. Surgical interventions, being invasive, irreversible procedures, have limited acceptance. Currently, no pharmacological treatments for presbyopia have been approved in China. There is a significant unmet medical need in the field of presbyopia for non-invasive, safe, effective, and reversible pharmacological therapies.

LENZ Therapeutics' Once-Daily, Novel Presbyopia Eye Drops Among Similar ProductsLNZ100 (1.75% cecledine)Approved for marketing by the U.S. FDA in July 2025. In Phase 3 studies, most subjects achieved significant improvement within 30 minutes after administering LNZ100, with efficacy lasting up to 10 hours. LNZ100, developed by LENZ Therapeutics, contains aceclidine as its active ingredient. Corxel Pharmaceuticals has obtained exclusive rights for the development and commercialization of LNZ100 in Greater China. In July 2025, Corxel Pharmaceuticals submitted a marketing application for LNZ100 ophthalmic solution in China.

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